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Job Information Number ICIMS-2025-9497 Job function Manufacturing Job type Temporary Location San Diego - WBH - 6260 Sequence Drive San Diego, California 92121 United States Country United States Shift 1st About the Position Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Position Summary: The Cuvettes Team Leader supports daily production and inventory management ensuring quality, production, efficiency, and timely delivery of existing and new/modified products to stock. As directed, the Cuvettes Team Leader also leads department staff in assigned daily tasks in support of manufacturing activities. The pay rate for this role is $28-$31/hr, depending on experience. Responsibilities Key Accountabilities Essential Functions: Execute assigned weekly production plan as per weekly schedule; operate a variety of manufacturing equipment as necessary Support daily production and packaging activities in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). Continually work to achieve assigned production goals; meet unscheduled peaks in workload as necessary to ensure timely release of product and to avoid back orders. Oversee inventory to ensure quality, production, and efficiency. Support business and staffing need to achieve effective manufacturing and control of products in compliance with all established manufacturing specifications and control procedures; assist with staff rotation, break scheduling, and shift transfer. Lead department training activities; maintain compliant training records. Ensure safe working conditions throughout the department at all times; adhere to all safety policies and procedures and support safety training and inanities. Ensure support for the transfer of technology (product) to routine manufacturing; evaluate new technologies and the pilot work that is required to assure minimum problems with initial and subsequent manufacturing. Support special projects as assigned by management. Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs. Identify production and manufacturing issues and work to implement corrective action. Work cross-functionally to coordinate corrective action for technical problems related to raw materials, finished products; minimize rejects and field complaints. Ensure and maintain compliance with the Companys quality system requirements through training and adherence to policies, procedures and processes. Other duties as assigned. Qualifications Minimum Knowledge & Experience Required for the Position: High school diploma or equivalent; additional training/education a plus. Three (3) to five (5) years previous related manufacturing experience within a regulated medical device manufacturing or pharmaceutical environment. Previous lead experience preferred. Understanding of coagulation-based manufacturing processes and company products. Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO. Working knowledge of Microsoft Office and large Enterprise Resources Planning (ERP) system preferred. Good written and verbal communication. Ability to work as part of a team. Ability to identify and correct problems. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com
Our MedTech Project Coordinator will support the SDS organization within our Medication Management Solutions (MMS) Business Unit by managing field action deliverables in compliance with our quality and regulatory requirements. These deliverables include supporting customer remediation for recalls (where applicable), preparing the remediation team for new recalls, contacting customers to schedule remediation efforts, and support financial reporting for Dispensing field actions. The Project Coordinator will have solid project management skills, attention to detail as well as strong process execution and analytical skills. As part of a remote team, the Project Coordinator will be expected to set his/her own work direction and complete tasks with minimal supervision. The Project Coordinator will be responsible for managing customer remediation associated with Field Actions, as well as other small projects, as needed. What you will be doing in the role: Plan, coordinate, and execute small project, as assigned Manage customer remediation for all applicable field actions Monitor and report on field action budget, both expense to date and forecast Attain required expertise in all databases that house product data for the platform (SAP, SharePoint) Attain a thorough knowledge of all BD processes for field actions/recalls Assist Senior Project Managers with preparing the remediation team for new field actions Contact customers to schedule remediation projects with the customer, including building out detailed remediation project schedules with customers. Job Requirements: HS Diploma minimum is required or higher degree is preferred. Excellent writing skills and the ability to communicate accurately and concisely in English Ability to gain new technical skills quickly Strong customer service skills and positive attitude Ability to communicate complex technical concepts in layman’s terms Advanced skills with Microsoft Office products and Salesforce Ability to meet tight deadlines and handle changing priorities Travel Requirement: This is a Remote; work from home position that requires Internet and the ability to be flexible in different time zones. The ideal candidate will be located physically on the East or West Coast working EST or PST. Preferred Attributes: Bachelor’s Degree in Engineering, Technology, or Life Sciences preferred. Two or more years of experience in project management, preferred Prior experience within a regulated industry (e.g., medical device, pharma, automotive, aerospace), preferred Managed/supported projects cross-functionally in an iterative, fast paced environment Excellent verbal and written communication skills required Strong analytical, problem-solving, and interpersonal skills High attention to detail while managing multiple complex deliverables and stakeholder groups required Ability to learn quickly, deal with ambiguity, take initiative and achieve results required IQVIA MedTech CFS takes the approach to helping customers drive healthcare forward in this challenging and fast-paced environment. We help customers accelerate results, improve patient outcomes, and unleash new opportunities. Benefits: This position is eligible for our Medical Benefits. Vaccine/Immunization/Hospital Credentialing Requirement: A required function of this job requires individuals to enter various healthcare facilities. Thus, upon selection, individuals must complete healthcare facility credentialing process. To obtain credentials, individuals must meet the immunization requirements specified by the facility. Individuals are typically required to have completed/up to date: Measles, Mumps & Rubella vaccine, Varicella (chicken pox) vaccine, Negative Tuberculosis (TB) Test, Tetanus, Diphtheria & Pertussis (Tdap) vaccine, Hepatitis B vaccine, Influenza vaccine (seasonal), and COVID-19 vaccine primary series (heavily enforced by most facilities, some require booster(s)). Please note, IQVIA complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons, however, our client’s requirements may supersede this. *Please note: Due to the nature of this role, it is not eligible for Visa sponsorship. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe The potential base pay range for this role is $27-$29 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. Under general supervision with detailed instruction for new work or a special assignment, this position is responsible for performing a wide variety of repetitive or standard electronic and /or mechanical assemblies and subassemblies. Determines and/or follows methods and sequence of operations in performing assembly tasks such as wiring, component installation, hand soldering and cable harnessing on assembly units. May monitor and verify quality in accordance with control procedures. This position is for the second shift. DUTIES AND RESPONSIBILITIES: Assembles components, assemblies or sub-assemblies. Makes setups and adjustments holding tolerances to specifications. May perform duties as required in assembly of electronic equipment such as cables, harnesses, chassis, and printed circuit boards, or may perform mechanical assembly of panels, LRU's, batteries, and servo motors. May disassemble, modify, rework, and reassemble assemblies or subassemblies. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Additional Functions: May assist in training lower level assemblers. Performs housekeeping and cleanup duties upon completion of assigned tasks. Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. 51599 Job Qualifications: Typical requires a high school diploma or equivalent and three or more years experience. Must be customer focused and possess: The ability to read and interpret engineering drawing and wire lists. Good understanding of the general aspects of the job with limited technical comprehension. Knowledge of computer operations and applications pertinent to the position. Familiarity with use of soldering and compression connection tools. Good visual perception and ability to distinguish between colors. The ability to work independently or in a team environment is essential as is the ability to work extended hours as required. Ability to obtain and maintain DoD Security Clearance is required. Salary:$44,590 - $66,295Travel Percentage Required 0 - 25Relocation Assistance Provided Not Provided US Citizenship Required? YesClearance Required? Desired Clearance LevelMid-Level (3-7 years) WorkstyleOnsite
At PwC, our people in operations consulting specialise in providing consulting services on optimising operational efficiency and effectiveness. These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance. In product development and manufacturing at PwC, you will specialise in improving product development and manufacturing processes. You will work closely with clients to analyse product development lifecycles, identify bottlenecks, and develop strategies to enhance speed to market, reduce costs, and improve quality. Working in this area, you will also provide guidance on implementing lean manufacturing principles, optimising supply chain integration, and leveraging digital technologies. Driven by curiosity, you are a reliable, contributing member of a team. In our fast-paced environment, you are expected to adapt to working with a variety of clients and team members, each presenting varying challenges and scope. Every experience is an opportunity to learn and grow. You are expected to take ownership and consistently deliver quality work that drives value for our clients and success as a team. As you navigate through the Firm, you build a brand for yourself, opening doors to more opportunities. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Apply a learning mindset and take ownership for your own development. Appreciate diverse perspectives, needs, and feelings of others. Adopt habits to sustain high performance and develop your potential. Actively listen, ask questions to check understanding, and clearly express ideas. Seek, reflect, act on, and give feedback. Gather information from a range of sources to analyse facts and discern patterns. Commit to understanding how the business works and building commercial awareness. Learn and apply professional and technical standards (e.g. refer to specific PwC tax and audit guidance), uphold the Firm's code of conduct and independence requirements. Basic Qualifications Minimum Degree Required Bachelor's Degree Preferred Qualifications Degree Preferred Master's Degree Preferred Fields of Study Biomedical Engineering,Computer Engineering,Engineering,Industrial and Operations Engineering,Industrial Engineering,Materials Science and Engineering,Project Engineering & Management,Production Engineering,Systems Engineering,Biomedical Science,Computer and Information Science,Data Processing/Analytics/Science Preferred Knowledge/Skills Demonstrates intimate knowledge and experience with and a proven record of success in leading or facilitating project management or client consultations in the areas of product development and manufacturing, preferably for a global network of professional services firms, in one of the following core industry sectors including, but not limited to: - Industrial: Automotive; Aerospace; Chemicals; Industrial Manufacturing; or, Construction; - Technology: Hardware/Electronics; Systems; Software; Semiconductor; or, Telecommunications; - Life Sciences: Pharma, Bio Pharma, & Specialty Pharma; Medical Device, Medical Technology & Diagnostics; Generics; or, Animal Health; and, - Consumer Markets: Food & Beverage; Goods; or, Vertically Integrated Retail. Demonstrates intimate knowledge and experience with and a proven record of success directing efforts in advisory services in the following capability areas: - Technical solution architecture for one or more of these technologies: Dassault 3DEXPERIENCE (3DX), Siemens Teamcenter, PTC Windchill, SAP PLM; - PLM Blueprint & Design for the above technologies - Digital Engineering/ PLM Strategy Development - Digital Engineering Application (PLM, ALM, PPM) Configuration and Deployment - Engineering Decision Support & Analytics; - Engineering Cloud Solutions;Ê - Product Development Strategy & Operations - Connected Products / Platforms / Services Demonstrates intimate abilities to lead and manage a diverse team including - Demonstrates the ability to build, maintain, and utilize networks of client relationships; - Possesses advanced problem solving and analysis skills; - Possesses advanced spreadsheet, presentation and document development skills; - Possesses detailed value case development skills; - Possesses the ability to interpret financial statements; - Possesses engaging interpersonal skills; - Possesses a collaborative and Ôcan-doÕ mindset; - Possesses financial modeling skills; - Possesses the ability to influence and shape thinking of peer level and Director level client resources; - Possesses Program/Project leadership skills - ability to lead complex multi-workstream projects; - Manages unstructured situations, anticipating client needs and developing solutions; - Possesses the ability to develop/coach resources and guide careers of team members; - Possesses client presentation skills; and, - Possesses proposal & pricing development skills. Learn more about how we work: https://pwc.to/how-we-work PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy. As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines The salary range for this position is: $63,000 - $140,000, plus individuals may be eligible for an annual discretionary bonus. For roles that are based in Maryland, this is the listed salary range for this position. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. We are looking for a passionate and innovative Advanced Airframe Project Engineer to join our Advanced Aircraft Engineering (AAE) team. In this role, you will lead the development of cutting-edge aircraft structures, working from requirements definition through conceptualization to flight testing. Join a team that’s shaping the future of unmanned aviation and making a tangible impact on aerospace technology. Opportunity Be part of a globally recognized leader in aerospace innovation. Work on advanced technologies that redefine the industry. Enjoy opportunities for career growth, leadership development, and collaboration with top talent. Make an impact by contributing to groundbreaking unmanned aerial systems. DUTIES AND RESPONSIBILITIES: Airframe Product Development & Project Leadership Lead airframe/structures sub-system projects. Coordinate across functional teams (Structural Design, Loads Development, Structural Analysis, Materials and Processes, Manufacturing, and Tooling). Develop requirements, internal statements of work, and project estimates for airframe structures. Supplier and Manufacturing Coordination Manage technical support for airframe structure suppliers, including statements of work and technical data packages. Facilitate design for manufacturing and assembly processes. Oversee the transition of designs to manufacturing, ensuring smooth integration. Team and Project Management Build and lead cross-disciplinary teams to execute project goals. Develop tactical execution plans aligned with program schedules and budgets. Manage project scope, risks, and technical challenges. Communication and Documentation Interact with internal and external stakeholders to resolve technical issues. Provide technical presentations and documentation as needed. What We Offer Competitive compensation and benefits package. Opportunities for professional development and certifications. A collaborative and inclusive workplace culture. Access to cutting-edge resources and tools in aerospace engineering. Hybrid working arrangement. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. 51700 Job Qualifications: Typically requires a bachelors degree, masters degree or PhD in engineering or a related technical discipline from an accredited institution and progressive engineering experience as follows; nine or more years of experience with a bachelors degree, seven or more years of experience with a masters degree, or four or more years with a PhD. May substitute equivalent engineering experience in lieu of education. The ability to understand new concepts quickly and apply them accurately throughout an evolving environment. Strong communication, presentation, and interpersonal skills. Proficiency in Microsoft Project and Excel. Hands-on experience with composite structures, including design, stress analysis, materials/process development, or manufacturing. Ability to work independently and collaboratively in a fast-paced environment. Ability to obtain and maintain a DoD Security Clearance required. Salary:$105,890 - $189,545Travel Percentage Required 0 - 25Relocation Assistance Provided Provided US Citizenship Required? YesClearance Required? Desired Clearance LevelSenior (8+ years) WorkstyleHybrid
Corporate Overview Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence. Position Overview The Manufacturing Associate II is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate II is expected to fully participate in both departmental projects and any quality working teams that may be applicable. This position shall be responsible for the hands on execution of activities as they relate to the manufacturing of products. All of the specific requirements presented in this job description are applicable to the functional area in which it resides. This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:30am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance. The pay range for this position is between $26.50 - $30.00 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. Responsibilities and Duties Manage and update the Kanban System. Manage sustaining documentation updates and providing review of NPI documentation. Manage equipment lifecycle including generating URS, onboarding and commissioning, generating calibration specifications, SOP and participating in IOQ. Perform Preventative maintenance on equipment. Must act as SME on multiple processes and be able to provide technical guidance. Participate in kitting and design for finished storage of products in shipping containers Must identify and implement effective continuous improvements Work interdepartmentally to drive lean initiatives Lead efforts in troubleshooting, root cause analysis, and corrective and preventive actions (CAPA) for deviations and non-conforming materials. Be proficient at NetSuite and able to investigate discrepancies. Be proficient at collaborating in MasterControl. Collaborate on validation protocol and assist in the execution of validation activities. Review manufacturability of NPI prior to execution. Perform Label Adhesive compatibility studies. Able to be SME and train operators on label generation. Be able to back up planning and scheduling. May perform other duties as assigned. Requirements and Qualifications Preferred: Bachelor's degree in a related field (Biotechnology, Molecular Biology, or Biochemistry) with at least 2+ years of work experience at Argonaut or in manufacturing within a cGMP environment. Associates degree in a related field (Biotechnology, Molecular Biology, or Biochemistry), with at least 3+ years of work experience at Argonaut or in manufacturing within a cGMP environment. High school diploma or equivalent with 5+ years of related in manufacturing within a cGMP environment. Punctuality and reliable attendance required. Ability to read and follow detailed written instructions; strong verbal and written communication skills. Proficient in reading, writing, and conversing in English to understand cGMP manufacturing processes and SOPs. Knowledge of manufacturing production processes related to product integrity, including visual inspection of components and finished goods, manual and semi-automated packaging, and product labeling. Understanding of basic chemical and biological safety procedures. Basic knowledge of formulation, filling, and kitting operations and capabilities. Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
Corporate Overview Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence. Position Overview The Manufacturing Associate II is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate II is expected to fully participate in both departmental projects and any quality working teams that may be applicable. This position shall be responsible for the hands on execution of activities as they relate to the manufacturing of products. All of the specific requirements presented in this job description are applicable to the functional area in which it resides. This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:30am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance. The pay range for this position is between $26.50 - $30.00 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. Responsibilities and Duties Manage and update the Kanban System. Manage sustaining documentation updates and providing review of NPI documentation. Manage equipment lifecycle including generating URS, onboarding and commissioning, generating calibration specifications, SOP and participating in IOQ. Perform Preventative maintenance on equipment. Must act as SME on multiple processes and be able to provide technical guidance. Participate in kitting and design for finished storage of products in shipping containers Must identify and implement effective continuous improvements Work interdepartmentally to drive lean initiatives Lead efforts in troubleshooting, root cause analysis, and corrective and preventive actions (CAPA) for deviations and non-conforming materials. Be proficient at NetSuite and able to investigate discrepancies. Be proficient at collaborating in MasterControl. Collaborate on validation protocol and assist in the execution of validation activities. Review manufacturability of NPI prior to execution. Perform Label Adhesive compatibility studies. Able to be SME and train operators on label generation. Be able to back up planning and scheduling. May perform other duties as assigned. Requirements and Qualifications Preferred: Bachelor's degree in a related field (Biotechnology, Molecular Biology, or Biochemistry) with at least 2+ years of work experience at Argonaut or in manufacturing within a cGMP environment. Associates degree in a related field (Biotechnology, Molecular Biology, or Biochemistry), with at least 3+ years of work experience at Argonaut or in manufacturing within a cGMP environment. High school diploma or equivalent with 5+ years of related in manufacturing within a cGMP environment. Punctuality and reliable attendance required. Ability to read and follow detailed written instructions; strong verbal and written communication skills. Proficient in reading, writing, and conversing in English to understand cGMP manufacturing processes and SOPs. Knowledge of manufacturing production processes related to product integrity, including visual inspection of components and finished goods, manual and semi-automated packaging, and product labeling. Understanding of basic chemical and biological safety procedures. Basic knowledge of formulation, filling, and kitting operations and capabilities. Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
LEGOLAND CA Hotel Supervisor-FT Location (Country-State-City) US-CA-Carlsbad Job ID 2025-10216 Employment Type Full-Time Offer/Contract Type At Will (US Only) Location Name LEGOLAND California Job Locations US-CA-Carlsbad What you'll bring to the team The Hotel Supervisor is responsible for assisting the Hotels Manger to oversee the Front of House area/functions and overall guest experience of the Hotel. Leading the Front Office team in welcoming guests to the hotel through the arrival process, departure process and all other services required throughout the guests’ stay. Develop and lead a positive, professional and strong team, with a focus on guest satisfaction, quality of service and delivery and development of a high level of skills. Act as a role model in leading this through The Merlin Way. Ensure all queries and complaints are dealt with accordingly and exceed guests’ expectations along the way OPERATIONS Monitor and review all activities in the Front Office areas to ensure there is adequate cover to reduce guest waiting times, maximize efficiency and friendly service, cleanliness, health and safety (e.g. luggage blocking areas, safety of children etc.) Responsible for managing all hotel outsourcing contracts Continually review guest waiting times and guest satisfaction Review service flow to ensure maximum efficiency and reduce time taken to manage guest interactions, speed of check in and check out, etc. Provide a balanced level of support and leadership to both the day and night teams in the hotel. Empower the relevant members of the team to make decisions in order to resolve guest issues and ensure a positive outcome. Responsible for maintaining the House in PMS. Routinely checks and responds to Reservation email requests and inquiries. Communicates with Housekeeping and Engineering on the status of all room statuses and discrepancies. BUSINESS IMPACT/RESULTS Monitoring of night staff performance. Ensure all cleaning is executed accordingly and to the correct standard. Ensure all Health and Safety documentation is recorded and up to date, including risk assessments. Communicate with Revenue Manager in terms of accuracy of night audit and other revenue related checks. Monitor and review inventory for all Front Desk and Front Office supplies and collateral. Required to adhere to, and maintain all policies relating to LEGOLAND California Resort. These controls include primary responsibility for the safeguarding of cash and Hotel revenues. To exceed targets within company set-out formal audits, including Health & Safety, HR, Finance and Control, Operations. Ensure there is adequate fire cover every night. Provide a balanced level of support and leadership to both the day and night teams in the hotel. Empower the relevant members of the team to make decisions in order to resolve guest issues and ensure a positive outcome. Ensure the whole team has a clear understanding of the exact nature of their roles and the importance of positive energy. Provide the relevant information, tools and training to the appropriate teams in order for them to deliver a high level of guest service. CREATIVITY Monitor and review guest feedback to identify and influence any guest satisfaction or additional revenue generating activity. Explore and feedback any other sales opportunities and revenue streams. Proactively seek to identify different methods of working and new products in order to maximize inefficiencies within the operation. Create and facilitate trainings that are motivating and based off operational needs. To ensure that the Front Office is compliant with brand and company operating procedures COMMUNICATION Directly responsible for all aspects of the daily Front Office operation, to ensure a continually superior Guest experience and standards of service and health and safety. Establishes, communicates and champions core standards throughout all guest facing areas. Work closely with the Hotels Manager in terms of striving to achieve the wider hotel objectives. Update the Hotels Manager on any operational issues in a timely manner, ensuring the earliest possible resolution and appropriate support in times of need. Deliver motivational and inspiring daily team briefs to ensure the team is up to date with any current issues and information they may need to be aware of. Establish a consistent way of communicating information to all staff in a 24 hour operation. DECISION MAKING & AUTONOMY Monitor and review operation of the department and implement changes to improve efficiency. To ensure that the Front Office operates effectively on a day to day basis, in line with company and brand standards, and that the appearance of the Front Office creates a professional impression to guests and employees To be on duty / on call at various times In accordance with the company procedures to manage positive and poor performance to ensure maximum productivity, team member satisfaction and minimizing labour turnover. Adhering to the company guidelines when recruiting team members and identifying those who are demonstrating The Merlin Way. APPLIED KNOWLEDGE & SPECIALIST SKILLS To review all business processes objectively and make recommendations to the Hotels Manager Develop a full working knowledge of the Front Office Operation in all areas of: Front Desk, PBX, Rooms Controller, and Reservations. Ensure all hotel SOPs, Risk Assessments and training (generic and specific) is carried out, reviewed, updated and recorded MANAGING RESOURCES Ensure team and departmental costs are kept within the agreed budget. Establish and promote an environment which encourages input, initiative and creative approaches through coaching, review, target setting, feedback and team area ownership. Ensure all employees receive regular training to update their skills and knowledge and meet their own personal development needs. To proactively monitor employee performance throughout the Front Office, advising and coaching front line MC’s as necessary to ensure appropriate actions are taken to readdress any poor performance, and to recognize superior performance Drive Front Office training plans and evaluate to ensure that the training is relevant and achieves the required outcome. To develop a cohesive and trained team who are able to execute superior guest service and budget control. Ensure team and department costs are kept within agreed budget. COMPLEXITY & PROBLEM SOLVING Creative ideas for delivery of guest satisfaction and operational targets. Act as an incident controller to provide support and recovery to the Hotel. Coordination of all rescue and evacuation activities for the hotel. Demonstrate ability to resolve difficult guest situations which result in a positive outcome. Provide guest recovery within the scope of the complaint provided. HEALTH & SAFETY You are responsible for all aspects of Health, Safety & Security within your team, in line with the Group Policy (HS001). In particular, you must ensure that risk assessments have been carried out, that safe working procedures are in place for all work activities and that all employees you are responsible for are aware of the Group Health, Safety and Security Policy and their obligations under it. You must ensure that safe working practices are monitored and that risk assessments and procedures are reviewed regularly. Where incidents do occur, you must ensure that they are investigated appropriately and that where necessary, corrective action is taken to ensure that such incidents are not repeated. Qualifications & Experience Education: Bachelor’s degree in Hospitality Management, Business Administration, or a related field preferred. Equivalent combination of education and experience may be accepted in lieu of a degree. Experience: Minimum 2–4 years of experience in hotel front office operations "preferred" 1–2 years in a supervisory or Assistant management role. Experience in themed or family-oriented resorts or attractions is a plus. Skills and Knowledge: Strong leadership and team development skills. Proficiency with Property Management Systems (PMS), ideally Opera or similar. Excellent communication, guest service, and problem-solving abilities. Knowledge of safety, health, and security regulations in hospitality operations. Physical Requirements A. Sitting: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) J. Wrist Deviation (Side to Side): 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) B. Standing: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) K. Hand/Wrist Repetitions (Up and Down): 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) C. Walking 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) L. Reaching: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) D. Lifts and Carries: Frequency: 1. Up to 10 pounds None Occasionally Frequently Constant 2. 11 to 24 pounds None Occasionally Frequently Constant 3. 25 to 34 pounds None Occasionally Frequently Constant 4. 35 to 50 pounds None Occasionally Frequently Constant 5. 51 to 74 pounds None Occasionally Frequently Constant 6. 75 to 100 pounds None Occasionally Frequently Constant 7. Over 100 pounds None Occasionally Frequently Constant E. Lifts Overhead: Frequency: 1. Up to 10 pounds None Occasionally Frequently Constant 2. 11 to 24 pounds None Occasionally Frequently Constant 3. 25 to 34 pounds None Occasionally Frequently Constant 4. 35 to 50 pounds None Occasionally Frequently Constant 5. 51 to 74 pounds None Occasionally Frequently Constant 6. 75 to 100 pounds None Occasionally Frequently Constant 7. Over 100 pounds None Occasionally Frequently Constant F. Twisting: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) M. Grasping: 1. Simple: < 50 pounds 2. Firm: > 50 pounds G. Bending: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) N. Manual Dexterity/Strength: 1. Gross motor, light-moderate strength 2. Gross motor, moderate - heavy strength 3. Fine motor, light-moderate strength 4. Fine motor, moderate - heavy strength H. Squatting/Kneeling/Crawling/ Climbing: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) O. Pushing: 1. None (0%) 2. Occasionally (1-33%) ___ lbs 3. Frequently (34-66%) ________ lbs 4. Constantly (67-100%) _______lbs I. Pulling: 1. None (0%) 2. Occasionally (1-33%) ______ lbs 3. Frequently (34-66%) ________ lbs 4. Constantly (67-100%) _______lbs Visual Requirements Hearing P. Visual Requirements: 1. Close eye work (small figures) 2. Color discrimination - Minimal color discrimination - Normal color discrimination 3. Other: Depth perception, distance vision, ability to focus. Q. Hearing Requirements: 1. Special requirements Able to consistently fulfill communication needs. (alarms, phone ringing, conversation, clear acuity within 100 feet) Working Conditions R. Temperature: 1. < 15 degrees Fahrenheit 2. Between 16 and 95 degrees 3. > 95 degrees U. Driving: 1. None (0%) 2. Occasional (1-33%) 3. Frequent (34-66%) 4. Constant (67-100%) S. Crawl Space/Cramped Position: 1. Exposed < 1 hour per day 2. Exposed 1-3 hours per day 3. Exposed 3-7 hours per day 4. Exposed > 7 hours per day V. Noise (loud/repetitive, < 85 decibels per OSHA Standard): 1. None (0%) 2. Occasional (1-33%) 3. Frequent (34-66%) 4. Constant (67-100%) T. Personal Protective Equipment (e.g. respiratory mask, etc.) 1. None (0%) 2. Occasional (1-33%) 3. Frequent (34-66%) 4. Constant (67-100%) Other W. Specify any other requirements or restrictions that should be considered . Benefits What You'll Get... Alongside company paid holidays, you can also look forward to enjoying a great benefits package, free tickets to Merlin attractions globally and 30% discount in our retail shops and restaurants. We want to ensure that everyone has the opportunity to perform their best at interview, so if you have additional requirements due to disability or ill health please get in contact with [email protected]. Pay Range USD $68,640.00/Yr.
LEGOLAND CA Entertainment Performer- PT Location (Country-State-City) US-CA-Carlsbad Job ID 2025-10217 Employment Type Part-Time Offer/Contract Type At Will (US Only) Location Name LEGOLAND California Job Locations US-CA-Carlsbad What you'll bring to the team Maintains the quality of the guest experience to the highest level possible, by playing a designated role in each performance to a consistently high standard as set by the show script and/or Director. Scope and Responsibilities: Ensures the prompt performance of each show by being present in the Park at call time. Is present during the running of all shows. Participates in the daily warm up routine as set by the Supervisor or Show Captain. Maintains a clean and safe backstage environment at all times. Ensures that all costumes are properly cared for, and that all props and equipment used are handled and stored correctly during and after shows, and at the end of each day. Assists in dealing with all emergency situations that may occur. Assists in maintaining the guest experience by keeping each show as set in rehearsals by the Director. Interacts with park guests both during, and in between all performances. Participates in the clean-up rehearsals as required to maintain the quality of the Show performance as required by the Entertainment Supervisor, or to train new MCs. Takes notes on performances if swung out the schedule. Cooperates with all Entertainment and LEGOLAND California Model Citizens. Responds to needs of the Entertainment Department during seasonal activities and special events. Qualifications & Experience Background and experience in theme park, live performance or special skill set (juggling, tumbling, balloon artist, etc.) is preferred. Requires excellent organizational and planning skills. Self motivated and demonstrated initiative. Leads by example with a demonstrated history of supporting colleagues, a team player. Strong problem solving skills and dedication to providing outstanding guest service. Requires the ability to remain calm under pressure. Education: Course work in Theater is preferred. Other Requirements: Must be willing to work flexible hours, including evenings and weekends to support park operations. Must pass a physical. Physical Requirements A. Sitting: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) J. Wrist Deviation (Side to Side): 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) B. Standing: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) K. Hand/Wrist Repetitions (Up and Down): 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) C. Walking 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) L. Reaching: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) D. Lifts and Carries: Frequency: 1. Up to 10 pounds None Occasionally Frequently Constant 2. 11 to 24 pounds None Occasionally Frequently Constant 3. 25 to 34 pounds None Occasionally Frequently Constant 4. 35 to 50 pounds None Occasionally Frequently Constant 5. 51 to 74 pounds None Occasionally Frequently Constant 6. 75 to 100 pounds None Occasionally Frequently Constant 7. Over 100 pounds None Occasionally Frequently Constant E. Lifts Overhead: Frequency: 1. Up to 10 pounds None Occasionally Frequently Constant 2. 11 to 24 pounds None Occasionally Frequently Constant 3. 25 to 34 pounds None Occasionally Frequently Constant 4. 35 to 50 pounds None Occasionally Frequently Constant 5. 51 to 74 pounds None Occasionally Frequently Constant 6. 75 to 100 pounds None Occasionally Frequently Constant 7. Over 100 pounds None Occasionally Frequently Constant F. Twisting: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) M. Grasping: 1. Simple: < 50 pounds 2. Firm: > 50 pounds G. Bending: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) N. Manual Dexterity/Strength: 1. Gross motor, light-moderate strength 2. Gross motor, moderate - heavy strength 3. Fine motor, light-moderate strength 4. Fine motor, moderate - heavy strength H. Squatting/Kneeling/Crawling/ Climbing: 1. None (0%) 2. Occasionally (1-33%) 3. Frequently (34-66%) 4. Constantly (67-100%) O. Pushing: 1. None (0%) 2. Occasionally (1-33%) ___ lbs 3. Frequently (34-66%) ________ lbs 4. Constantly (67-100%) _______lbs I. Pulling: 1. None (0%) 2. Occasionally (1-33%) ______ lbs 3. Frequently (34-66%) ________ lbs 4. Constantly (67-100%) _______lbs Visual Requirements Hearing P. Visual Requirements: 1. Close eye work (small figures) 2. Color discrimination - Minimal color discrimination - Normal color discrimination 3. Other: Depth perception, distance vision, ability to focus. Q. Hearing Requirements: 1. Special requirements Able to consistently fulfill communication needs. (alarms, phone ringing, conversation, clear acuity within 100 feet) Working Conditions R. Temperature: 1. < 15 degrees Fahrenheit 2. Between 16 and 95 degrees 3. > 95 degrees U. Driving: 1. None (0%) 2. Occasional (1-33%) 3. Frequent (34-66%) 4. Constant (67-100%) S. Crawl Space/Cramped Position: 1. Exposed < 1 hour per day 2. Exposed 1-3 hours per day 3. Exposed 3-7 hours per day 4. Exposed > 7 hours per day V. Noise (loud/repetitive, < 85 decibels per OSHA Standard): 1. None (0%) 2. Occasional (1-33%) 3. Frequent (34-66%) 4. Constant (67-100%) T. Personal Protective Equipment (e.g. respiratory mask, etc.) 1. None (0%) 2. Occasional (1-33%) 3. Frequent (34-66%) 4. Constant (67-100%) Other W. Specify any other requirements or restrictions that should be considered . See requirements above. Must pass a physical. Benefits Alongside company paid holidays, you can also look forward to enjoying a great benefits package, free tickets to Merlin attractions globally and 30% discount in our retail shops and restaurants. We want to ensure that everyone has the opportunity to perform their best at interview, so if you have additional requirements due to disability or ill health please get in contact with [email protected]. Pay Range USD $23.00/Hr.
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! MEDICAL DIRECTOR - DRUG SAFETY PHYSICIAN SUMMARY: The Medical Director, Drug Safety Physician, collaborates with the Product Lead or Head of Drug Safety and is responsible for the clinical safety strategy for assigned drug projects and products. They provide drug safety expertise and guidance to Clinical Development, the Safety Oversight Committee (SOC), and the Clinical Project Teams, while also leading the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Major areas of responsibility include continuous efficient evaluation of safety data to perform signal detection and evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with cross-functional teams in support of the products and Ionis business partners. This position reports to the Safety Team Lead of assigned products. RESPONSIBILITIES: Performs individual case report assessment and determines regulatory reporting responsibilities as required Provides medical review of case narratives for medical content, accuracy, and signal detection Interpret aggregate safety data for periodic reports and evaluating for potential new signals Provides support and is capable of leading signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds, including ability to author signal report in response to Health Authority inquiries Provides support and can lead risk management and risk mitigation activities, including medical and safety leadership for RMPs Writes individual case assessments and evaluates aggregate safety data for periodic reports as required Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of compounds in clinical development Offers medical judgment on complex safety issues Works cross functionally with clinical to determine the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project’s medical monitor Supports and can present safety data to DSMBs for assigned products Collaborates with partner company’s drug safety team and clinicians, and provisions regular safety summaries Contributes to/reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products Participates in cross-functional project teams; communicates across organizational levels and functions Participates in SOP updates, audits, and inspection readiness Writes/updates core safety information for assigned projects Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e., protocols, IBs, ICFs, CSRs, IND/MAA submissions, RMP, annual reports, etc.) Prepares and/or reviews safety documents (DSURs, PBRERs, 6MLL, etc) and provides strategic input into responses to regulatory inquiries Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners May assist in due diligence activities May provide support to Legal for product liability litigation, as appropriate Supports the medical coding group on an ad hoc basis Participates in reconciliation procedures Guides and/or trains external personnel/parties involved in Ionis’ clinical studies Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers Maintain clinical and technical expertise in the therapeutic areas in which Ionis operates (i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.) May support and/or contribute to writing of white papers and other internal scientific publications Assist in accomplishing department and corporate objectives May participate/present safety material to Investigator’s meetings and other medical meetings Participates in selection and bidding activities for vendors and contractors Managerial responsibilities as required Other duties and ad hoc activities as assigned REQUIREMENTS: Medical degree (e.g., MD, MBBS) At least 5 years of clinical experience post-registration High level of medical competence, with an ability to balance this with industry standards to achieve business goals At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities. Able to work across therapeutic areas and functions Works collaboratively (establishes shared purpose across boundaries) Develops people and the organization (invests in long-term development of others) Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003864 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded The pay scale for this position is $246,875 to $350,620 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! EXECUTIVE MEDICAL DIRECTOR, DRUG SAFETY & PHARMACOVIGILANCE SUMMARY: The Executive Medical Director of Drug Safety, working with the head of drug safety, is responsible for the clinical safety strategy for assigned drug projects and products, provides drug safety expertise and guidance to Clinical Development, Safety Oversight Committee (SOC) and the Clinical Project Teams, and drives proactive implementation of risk management initiatives in accordance with global regulatory requirements. Major areas of responsibility include continuous efficient evaluation of safety data to perform signal evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with Ionis partners. This position reports to the VP and Head of Drug Safety. RESPONSIBILITIES: Performs individual case report assessment and determines regulatory reporting responsibilities as required Provides medical review of case narratives for medical content, accuracy, and signal detection Interpret aggregate safety data for periodic reports and evaluating for potential new signals Provides support and is capable of leading signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds, including ability to author signal report in response to Health Authority inquiries Provides support and can lead risk management and risk mitigation activities, including medical and safety leadership for RMPs Writes individual case assessments and evaluates aggregate safety data for periodic reports as required Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals Director/Drug Safety Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of compounds in clinical development Offers medical judgment on complex safety issues Works cross functionally with clinical to determine the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project’s medical monitor Supports and can present safety data to DSMBs for assigned products Collaborates with partner company’s drug safety team and clinicians, and provisions regular safety summaries Contributes to/reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products Participates in cross-functional project teams; communicates across organizational levels and functions Participates in SOP updates, audits, and inspection readiness Writes/updates core safety information for assigned projects Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e., protocols, IBs, ICFs, CSRs, IND submissions, annual reports, etc.) Prepares and/or reviews safety documents and provides strategic input into responses to regulatory inquiries Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners May assist in due diligence activities May provide support to Legal for product liability litigation, as appropriate Supports the medical coding group on an ad hoc basis Participates in reconciliation procedures Guides and/or trains external personnel/parties involved in Ionis’ clinical studies Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers Maintain clinical and technical expertise in the therapeutic areas in which Ionis operates (i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.) May support and/or contribute to writing of white papers and other internal scientific publications Assist in accomplishing department and corporate objectives May participate/present safety material to Investigator’s meetings and other medical meetings Participates in selection and bidding activities for vendors and contractors Managerial responsibilities as required Other duties and ad hoc activities as assigned REQUIREMENTS: Medical degree (e.g., MD, MBBS) At least 10 years of clinical experience post-registration High level of medical competence, with an ability to balance this with industry standards to achieve business goals At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities. Director/Drug Safety Able to work across therapeutic areas and functions Works collaboratively (establishes shared purpose across boundaries) Develops people and the organization (invests in long-term development of others) Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003865 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded The pay scale for this position is $270,530 to $378,004 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
We welcome you to apply if interested! You will be asked to create an account, which takes less than one minute and requires only a username and password. The entire application takes no more than 5-7 minutes to complete. Position Description: Our Material Handlers I (GL) experience a unique opportunity to utilize their previous work experience in an effort to advance their careers into the medical device industry. This position is based in San Diego, CA. IQVIA takes the approach to helping customers drive healthcare forward in this challenging, fast-paced environment. We help customers accelerate results, improve patient outcomes, and unleash new opportunities. We are hiring immediately with an expected start date of ASAP. You will have a flexible schedule and an opportunity to grow and expand into new opportunities while earning supplemental income and learning the medical device industry. Job Requirements: · 0-2 years’ experience in a warehouse environment preferred · Ability to lift 50 lbs. · Dependable and reliable • Ability to travel onsite to San Diego, CA • Ability to work shifts (if required) • Must be able to wear applicable personal protective equipment (PPE) in designated areas as required always including safety glasses. • Ability to sit and or stand for long periods of time with frequent walking, stooping, reaching, grasping, and using fine & gross motor manipulation. * Active and unrestricted driver's license Responsibilities: Ability to lift and maneuver boxes or equipment that are 50 lbs. or heavier Dependable and reliable worker who takes direction well Mixes cleaning solutions, cleans and decontaminates incoming instruments as needed in accordance with work instructions or manufacturing recommendations Organizes service worksheets and customer paperwork, transports instruments throughout the service department. Receives incoming shipments from freight carriers, unpacks and examines returned goods and associated records to determine nature of the return. Warehouses returned products for reconditioning, evaluation and loaner requirements. Scraps products no longer needed and processes waste materials for vendor pick up. Processes service records after product servicing, packages products as specified by Bills of Material, includes Service Report and shipping or Quality documents with products processed, prioritizes shipments based on customer needs. Stocks inventory in shipping area and maintains UPS equipment. The pay range for this role is $18.00/hour (Materials Handler I (GC). The actual pay will vary based on qualifications and competencies. Certain roles are eligible for annual bonus, sales incentives and/or stock. Benefits may include healthcare, retirement, paid time off, and more. Duties may require compliance with client requirements that all those performing services on-site be fully vaccinated. #LI-CES #LI-DNP IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe The potential base pay range for this role is $18.00-$20.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.