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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! ASSISTANT DIRECTOR, PATIENT ADVOCACY Ionis is seeking an exceptional candidate to support the patient advocacy team in designing, developing, and delivering collaborations and initiatives that advance shared priorities and make a meaningful impact in the lives of people living with challenging illnesses. The Assistant Director, Patient Advocacy will provide patient advocacy leadership and support to clinical-stage Ionis programs, such as ION269 and ION464. The successful candidate will develop and execute strategic advocacy engagement plans, serve as the key point of contact for key internal and external stakeholders, and be responsible for achieving advocacy engagement objectives. Responsibilities: Develop and execute strategic advocacy plans to support the advancement of clinical-stage programs Analyze the external stakeholder landscape to identify and prioritize potential partner organizations and individuals Identify, initiate, and oversee strategic patient advocacy initiatives and partnerships related to providing the patient perspective into research, informing the design and execution of clinical trials, delivering community education, and supporting access to appropriate care Align and collaborate directly with cross-functional internal teams including, but not limited to Clinical Development, Medical Affairs, Corporate Communications, Commercial, and Market Access Be the key relationship manager for global patient advocacy groups; lead and facilitate regular communications to advance mutually beneficial priorities Represent the company at external advocacy group meetings, make presentations to patient audiences Lead initiatives to understand, document, and communicate the patient perspective; including advisory boards, patient perspective research, etc. Assist in the creation, enhancement, delivery, and accessibility of community awareness programs for investigational medicines or commercial products Ensure high-quality communications materials are produced on time and error free, such as presentations, patient materials, Q&As, etc. Ensure adherence to legal and compliance frameworks that enable the company’s relationships with advocacy stakeholders to be respectful and appropriate Keep abreast of new developments and ideas in the field of patient advocacy and incorporate such developments, ideas, and strategies into the development and execution of programs in support of company priorities Support Advocacy-led internal employee engagement activities that spotlight the communities we serve Requirements: Bachelor’s degree required; advanced degree preferred (e.g., MS, MPH) Minimum of 8 years of relevant patient advocacy, communications, commercial, or related experience in the biopharmaceutical and associated industries; 5 years with advanced degree Proven understanding of the needs of individuals living with challenging illnesses Passion for making a positive impact in people’s lives Demonstrated knowledge of the biopharmaceutical industry, including of the Legal, Regulatory, and Compliance environment Experience assisting with or leading patient advocacy engagement activities for pre-commercial investigational medicines Understanding of guidelines and best practices for patient advocacy engagement in the US and Europe Strong written and verbal communication skills, as well as strong interpersonal skills, with impeccable attention to detail Strong leadership skills with a proven ability to collaborate effectively with internal and external stakeholders at all levels Highly motivated individual with the flexibility and creativity to excel in a rapidly growing and changing environment; confidence and organizational skills to independently work on multiple tasks Must be willing and able to travel (approximately 20-25%) and regularly meet with patient advocacy organizations in the US and internationally (as needed) Preferred work location is one of our offices in Carlsbad, CA (HQ) or Boston, MA Preferred Carlsbad, CA (Boston, MA or Remote acceptable for the right candidate) Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003790 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 $121,909 to $169,014 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.
Corporate Overview Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. 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 the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence. Benefits and Pay Range At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy: Medical, Dental, and Vision Insurance Company-Paid Life Insurance (1x Annual Salary) Voluntary Life Insurance Options Short-Term and Long-Term Disability Insurance Flexible Spending Account (FSA)Health Savings Account (HSA) 401(k) Retirement Plan with Company Matching 14 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $31.00 - $32.00 per hour. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Position Overview The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing. 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 7:00 am - 9:00 am with a consistent schedule. Duties and Responsibilities Perform various routine manufacturing tasks under the direction of internal SOP's and cGMP guidelines Prepare material components for manufacturing operations Document steps clearly and completely in production batch records, logbooks and other controlled forms Participate in inspection readiness activities Perform basic arithmetic and algebraic computation Maintain cleanliness of areas and equipment Assist senior level personnel in bulk drug formulation using a variety of lab equipment including mixers, balances, pH meters, etc., gowned in accordance with Class C (ISO 7) conditions Assist senior level personnel in sterile filtration activities, gowned in accordance with Class C (ISO 7) conditions Assist senior level personnel in sterile filling of a multitude of solutions including drug product, media, buffers, using an automated filling and closing machine, gowned in accordance with Class C (ISO 7) conditions Collect and dispose of lab wastes according to established procedures Collaborate in continuous improvement activities Education and Experience Requirements High school diploma or equivalent with 1 - 2 years relevant experience is required, a Bachelor's in an Engineering discipline or Life Science field preferred Time and project management skills with the ability to multi-task are essential Must be able to effectively communicate within department and cross-functionally with other divisions High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business, is a plus 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 with 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. 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 the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence. Benefits and Pay Range At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy: Medical, Dental, and Vision Insurance Company-Paid Life Insurance (1x Annual Salary) Voluntary Life Insurance Options Short-Term and Long-Term Disability Insurance Flexible Spending Account (FSA)Health Savings Account (HSA) 401(k) Retirement Plan with Company Matching 14 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $21.00 - $24.00 per hour. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Position Overview The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing. 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 7:00 am - 9:00 am with a consistent schedule. Duties and Responsibilities Perform various routine manufacturing tasks under the direction of internal SOP's and cGMP guidelines Prepare material components for manufacturing operations Document steps clearly and completely in production batch records, logbooks and other controlled forms Participate in inspection readiness activities Perform basic arithmetic and algebraic computation Maintain cleanliness of areas and equipment Assist senior level personnel in bulk drug formulation using a variety of lab equipment including mixers, balances, pH meters, etc., gowned in accordance with Class C (ISO 7) conditions Assist senior level personnel in sterile filtration activities, gowned in accordance with Class C (ISO 7) conditions Assist senior level personnel in sterile filling of a multitude of solutions including drug product, media, buffers, using an automated filling and closing machine, gowned in accordance with Class C (ISO 7) conditions Collect and dispose of lab wastes according to established procedures Collaborate in continuous improvement activities Education and Experience Requirements High school diploma or equivalent with 1 - 2 years relevant experience is required, a Bachelor's in an Engineering discipline or Life Science field preferred Time and project management skills with the ability to multi-task are essential Must be able to effectively communicate within department and cross-functionally with other divisions High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business, is a plus 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 with 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. Benefits and Pay Range At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy: Medical, Dental, and Vision Insurance Company-Paid Life Insurance (1x Annual Salary) Voluntary Life Insurance Options Short-Term and Long-Term Disability Insurance Flexible Spending Account (FSA)Health Savings Account (HSA) 401(k) Retirement Plan with Company Matching 14 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $20.00 - $22.00 per hour. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Position Overview The purpose of this position is to participate in tasks related to the visual inspection of manufactured liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing as well as other types of visual inspection activities, as required. This role is 100% on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00 am - 9:30 am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance. Responsibilities and Duties Perform visual inspection of pharmaceutical or medical products to identify defects or non-conformities. Ensure all inspected products meet established quality standards and regulatory requirements. Document results accurately in batch records or electronic systems. Maintain good documentation practices (GDP) and ensure inspection areas comply with aseptic and cleanliness standards. Operate and maintain inspection equipment and booths according to SOPs. Report defective products or process deviations to quality or production supervisors. Follow Good Manufacturing Practices (GMP) and safety protocols at all times. Participate in inspection and manufacturing readiness activities. Maintain cleanliness and organization of inspection areas, including gowning in all lab areas. Requirements and Qualifications High school diploma or equivalent required; 0-2 years of relevant experience. A Bachelor's degree in an engineering discipline or life science field is preferred. Must be able to effectively communicate within department and cross functionally with other divisions. High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction. Familiarity with GMP guidelines, including USP<790> and USP<1790>, and 21CFR 210/211 Proficiency in Microsoft Office; including Word, Excel, and Overlook 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.
Looking for a hands-on technical Manger to support product development by leading an engineering team focused on developing innovative technologies for the spine market. This individual will have ultimate responsibility for the execution of the team they lead, and delivery of products to market. Involved in identifying opportunities for innovation, enhancing the company’s existing products and determining product end of life, while also driving deeper engagement within the engineering department towards the organization’s top priorities. Additional responsibilities include identifying ways to streamline the new product development process and enhancing cross functional relations to ensure we are driving procedural efficiencies across departments. This role will be responsible for the technical and professional growth of the engineering team that they lead. This role will have direct surgeon interactions. Essential Duties and Responsibilities Independently responsible for the design, development, and processing of new medical products with integrated electro-mechanical and software technology, as well as related procedures and instruments. Develops the technical skills and directs the professional growth of an engineering team. Leads the development of new products and manufacturing processes and/or serves as a leader of a project team. Manages the development of working prototype models to be used for project design evaluation. Generates protocols for testing and analyzing new and current products. Generates design assurance documentation for the project Design History File (DHF). Develops quality control procedures and inspection methods Initiates design changes relative to manufacturability while maintaining critical features of each product for in house manufacturing or vendors Leads and/or serves on cross-functional product development teams responsible for new product development from concept through product launch. Provides technical input to marketing counterparts on the development of collateral marketing materials Provides technical expertise to marketing and sales as to intent of design function. Provides technical experience to Regulatory Affairs to support FDA 510K submissions. Creates and processes Engineering Change Orders (ECO’s) Other duties as assigned. Requirements The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience with 3D CAD system, preferably Solidworks Experience with phase gate design control processes Demonstrated success in leading cross-functional product development teams from concept through product launch, including demonstrated planning, organizing and time management skills. Ability to work with other disciplines in a cross functional core team including software, firmware, electrical, systems, regulatory and quality functions. Leadership: a demonstrated ability to lead people and get results through others Ability to think strategically, evidence of innovative thinking and high energy Proven participation and leadership with cross-functional core teams A full and complete knowledge of the medical marketplace and the ability to continuously evaluate trends and adjust strategy to compensate and take advantage of shifts Expert experience in product design procedures and project development methodology in the medical device industry. Strong technical skills in product development. Ability to evaluate the designs of direct reports to assure technical excellence. Strong analytical skills and creative problem-solving skills Extensive experience of manufacturing methods including machining, sheet metal, injection molding and electronic device manufacturing. Experience in sterile disposable devices a plus. Knowledge in the use and interpretation of geometric dimensioning and tolerancing Strong verbal and written communication skills; comfortable presenting to senior management 1+ years of supervisory experience Supervisory Responsibilities Directly supervises Product Development Engineering team. Education and Experience Undergraduate degree in Mechanical or Biomedical Engineering or related field, Graduate degree preferred. 7-10 year’s experience as a Product Development Engineer or similar role and 1 year minimum supervisory experience. Experience with product design using 3D CAD system, phase gate design control processes, cross-functional product development team experience, manufacturing methods for use with metal and plastic material inputs, and geometric dimensioning and tolerancing. Collaboration experience with multidisciplinary teams and a full understanding of the product development, marketing function, operating room specialties and procedures, and a successful history capturing market share. Prior successful development and launch of medical products through full lifecycle also required. For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable). ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws. Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $145,000 to $170,000 Full-Time Annual Salary