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With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Production Services Associate II is responsible for supporting both downstream and upstream production in a cGMP manufacturing environment. The Production Service team prepares buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down of operational equipment in accordance with the operations schedule. This role requires strict adherence to cGMP and standard operating procedures. Responsibilities Perform a variety of complex tasks in accordance with cGMP Operate and maintain production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Maintain/Perform daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Order, maintain, and stock supplies as directed (i.e. gowning, emergency kits, ect.) Documentation/verification of task completion in accordance with cGDP, SOPs and Batch Records. Monitor and maintain appropriate inventory levels of raw materials required for buffer and media prep. Manage a flexible work schedule where shift work may be required. Conduct activities in support of production schedules as directed by senior staff. Support floor operations for multiple projects simultaneously. Crosstrain on various tasks including Upstream/Downstream cGMP manufacturing. Operate in both a team and individual setting. Follow detailed instructions and maintain accurate records. Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique. Operate to the highest ethical and moral standards. Communicate effectively the status of floor operations to leads. Participate effectively as a team player in all aspects of Abzena's business. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Perform other duties as assigned. Qualifications 2-4 years of experience in cGMP manufacturing environment, preferably with buffer/media prep. A high school diploma is required. Technical degree in related field preferred. Knowledge and understanding of cGMPs. Experience using single-use technologies and disposable systems. Wear and maintain the required PPE to protect product integrity and ensure personal safety. Physical Requirements Physical ability to walk and stand for extended periods of time. Frequently lift and or move objects up to 30 pounds. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus. Values above to not include shift differentials FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
Production Planner Monday – Friday, 7:30 am - 4:00 pm About Us At Argen, we’re in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. We have a team of 400 Awesome team members. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with a product offering that span fixed, removable, ortho, implants, and equipment. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen’s products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed. About the Opportunity Creates, reviews, amends, and maintains attainable and effective production schedules for assigned products and product families, which has a significant impact on customer service and shop floor activity and therefore must be a creative thinker with sound decision making ability that acts with the customer in mind. In this role, the successful candidate will: Executes ERP and the timely creation of shop orders to satisfy customer demand, achieve desired levels and maintain flow of work on the factory floor. Utilizes system tools inclusive of material requirements planning and capacity planning to ensure that the supply chain is effective in meeting the needs of our customers while maintaining required delivery and inventory goals. Communicates and coordinates with production supervisors and purchasing team to ensure schedule adherence and recovery if required. Initiates and participates in continuous improvement activities related to production planning, customer service and inventory management. Reviews and maintains QAD data integrity inclusive of routings and bill of material accuracy. Manages and maintains inventory levels ensuring uninterrupted supply of parts while maintaining optimal inventory levels, along with ensuring customer reliability and meeting target inventory turns. Tracks progression of production orders, investigate factors that affect schedules, and modify plans as necessary. Expedites critical orders throughout the supply chain. Informs management of potential production problems and assist in the implementation of both short- and long-term solutions. Analyzes forecasted demand to ensure safety stock and strategic inventory levels on finished goods are maintained. Performs planning functions required to achieve the timely and successful launch of new products and participates as assigned on new product development teams. Other duties as assigned. What does it take to be successful? High school diploma or equivalent required. Bachelor’s Degree from an accredited institution in a related field is preferred. 3 + years of experience in production scheduling in a manufacturing environment required. APICS/CPIM certification preferred. Experience using QAD, preferred or SAP (forecasting tools and system overall). Experience in ERP Planning. Experience using analytical spreadsheet tools as well as other MS Office applications. Experience working with Microsoft Access and writing queries to analyze data. Ability to handle multiple tasks along with excellent time management skills and customer service skills. Strong interpersonal and conflict resolution skills to effectively interface with production, customer service, and management. Ability to conceptualize, define and resolve complex problems. Excellent analytical, problem solving and facilitation skills. Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred. Our Awesome Benefits! Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefit package that includes: Health Plans Dental Plans Vision Plan 401k with Employer Match Paid Time Off and Paid Holidays Employee Events Wellness Programs Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more! EOE/M/F/Vet/Disabled VEVRAA Federal Contractor Mon-Fri 7:30am-4:00pm
Compensation for roles at Glanbia varies depending on a wide range of factors including but not limited to the specific office location, role, skill set and level of experience. Glanbia provides a reasonable range of compensation for roles that may be hired in Illinois. This range may not be applicable to other locations. The hourly rate for California based employees for this role is $21.12/hour. At Glanbia Nutritionals Inc., our portfolio centers on dairy and non-dairy nutritional ingredients. We co-innovate and deliver ingredient solutions and precision premixes for use in the mainstream food and beverage, infant and clinical, and functional nutrition markets. We are the number one provider of whey-based nutritional ingredients globally and the number one producer of American-style cheddar cheese. Our protein systems have transformed the bar and beverage categories — bringing increased levels of protein, cleaner labels and greater product functionality to market. We have a direct presence in 21 countries, with manufacturing facilities in the US, Germany and China, and international sales and technical offices around the world. Job Summary Responsible for the preparation, production and packaging of blend material. Provides assistance to the operator and fills in for basic operator duties as assigned. Maintain blend equipment and production area cleanliness. Must complete all applicable SOP and QA trainings. Essential Functions Box Room duties - tape boxes, insert foil/plastic liners, apply labels to boxes Label bags, Zip tie liners, Tape filled boxes, Palletize boxes Hand clean separators, air flows, heat sealers, conveyors, scales, metal detectors Clean drains Prepare cell for wash - cover electronics, remove scan gun, apply appropriate LOTO Able to identify status of equipment and cell Operate hand jack and power jack (certified) Inspection of raw material and /or fill IBC Gather tools and supplies from tool room for blends or wash Operate conveyor metal detector, includes HACCP metal checks Basic Sampling / Aseptic Sampling Scale Check Scan in blends to NOAX Manufacturing and Inspection Cell Release Discharge blenders out of separator (not at line speed) Seal foil and plastic liners Able to assist the operator with all blending, milling, packing tasks Identify ingredient name, lot number and item number Operate High Pressure washer and Foamer Read and understand sequence of steps on BPR Screen, blend and package a variety of amino acids, vitamins and minerals, including those which are allergenic. Responsible for following the procedures for the preparation of blends and final blend product. Proper cleaning, blending, packaging and material inspection per Standard Operating Procedures. Proper cleaning of manufacturing equipment and production floor. Assist with routine maintenance on manufacturing equipment as requested by the Operator. Regular attendance is an essential function of this position. Following and living Glanbia values: Showing Respect, Winning Together, Finding a Better Way, Performance Matters, and Customers Champion. Each employee shall comply with occupational safety and health standards and all rules, regulations, and orders issued pursuant to the Occupational Safety and Health Act which are applicable to his/her own actions and conduct. Complies with all applicable food safety regulations and mandates Additional Functions Perform other duties as assigned Qualifications High School Diploma or GED preferred. Ability to work with amino acids, vitamins and fine chemicals in powder and liquid form as well as allergen products. Ability to follow direction and work with Standard Operating Procedures. Must be able to work flexible hours to include overtime and weekends on short notice Clear command of the English language both verbal and in writing. Basic computer knowledge. Typical Physical Activity Physical Demands The physical demands described represent those that must be met by an employee and the work environment characteristics are those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. · Regularly involves talking or listening, sitting, and the use of hands and fingers. · Regularly involves going up and down stairs. · Frequently involves reaching with hands and arms, standing and walking. · Occasionally involves crouching, stooping, kneeling and/or climbing or balancing. Physical Requirements Must be able to lift and carry items weighing up to 55 pounds. Manual dexterity sufficient to reach/handle items, works with the fingers, and perceives attributes of objects and materials. Involves moderate physical activity performing non-strenuous daily activities of a primarily administrative nature. Should be able to identify and distinguish colors, see clearly at 20 inches or closer and 20 feet or more, observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point, judge distances and spatial relationships, and adjust the eye to bring an object into sharp focus. Typical Environmental Conditions May be exposed to moderate noise levels (i.e. office equipment, light traffic). May be exposed to moderate to high noise levels (i.e. production equipment, forklifts, heavy traffic). May be exposed to humidity, intense heat and cold, outdoor weather conditions, and fumes and toxic chemicals. May work in areas with mechanical moving parts, above ground with risk of fall, or areas with risk of electrical shock. Travel Requirements N/A Compensation Compensation for roles at Glanbia varies depending on a wide range of factors including but not limited to the specific office location, role, skill set and level of experience. Glanbia provides a reasonable range of compensation for roles that may be hired in CA. This range may not be applicable to other locations. Factors that could be used to determine your actual salary may include your specific skills, years of experience and comparison to current employees already in this role. The hourly rate for CA based employees for this role is $21.12. Disclaimer Must perform the essential duties and responsibilities with or without reasonable accommodation efficiently and accurately without causing significant safety threat to self or others. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified. At Glanbia, we celebrate diversity, because we know that our individual strengths make us stronger together. We welcome and encourage interest from a wide variety of candidates, and we will give your application consideration, without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. At Glanbia our culture will celebrate individuality, knowing that together we are more.
*We are a growing perfume brand with a creative small-batch lab in San Diego. We are seeking an experienced fragrance professional — perfumer, fragrance chemist, or compounder* — to support our production on a consulting basis. *Responsibilities* * Lead small-batch perfume compounding (weighing, mixing, blending). * Ensure compliance with IFRA and OSHA safety standards. * Develop and implement Standard Operating Procedures (SOPs). * Train staff in ingredient handling and quality control. * Advise on ingredient sourcing and storage best practices. *Qualifications* * Experience in fragrance compounding, cosmetic chemistry, or perfume production. * Strong knowledge of fragrance ingredients, IFRA guidelines, and alcohol handling. * Detail-oriented, reliable, and professional. * Passion for fragrance creation and knowledge sharing. *Engagement & Compensation* * Consulting / project-based (flexible hours). * On-site in San Diego (some remote possible). * *$40–$80/hr* depending on experience (project fee negotiable). *To apply, please send your resume, experience, and availability.* Job Type: Full-time Pay: $40.00 - $80.00 per hour Expected hours: 20 – 40 per week Application Question(s): * Do you have previous experience with fragrance compounding or cosmetic chemistry? * Are you familiar with IFRA guidelines and safe handling of flammable materials? * Have you created or implemented production SOPs and trained team members in a lab or small-batch environment? Ability to Commute: * San Diego, CA 92126 (Required) Work Location: Hybrid remote in San Diego, CA 92126
San Diego, CAManufacturing – Manufacturing /Full Time /On-Site With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Production Services Associate I will be responsible for supporting both downstream and upstream production in a cGMP manufacturing environment. The Production Services team prepares buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down of operational equipment, in accordance with the operations schedule. This role requires adherence to cGMP and standard operating procedures. Responsibilities Perform a variety of complex tasks in accordance with cGMP. Operate and maintain production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Perform daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Maintain and stock supplies as directed. (i.e. gowning, and emergency kits, ect.) Documentation/verification of task completion in accordance with cGDP, SOPs and Batch Records. Manage a flexible work schedule where shift work may be required. Conduct activities in support of production schedules as directed by senior staff. Support floor operations for multiple projects simultaneously. Crosstrain on various tasks including Upstream/Downstream cGMP manufacturing. Operate in a team setting. Follow detailed instructions and to maintain accurate records. Set up equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique. Operate to the highest ethical and moral standards. Comply with Abzena's policies and procedures. Communicate effectively in a team environment. Participate effectively as a team player in all aspects of Abzena's business. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Perform other duties as assigned. Qualifications 0 – 2 years of experience in manufacturing production. A high school diploma is required. Knowledge and understanding of cGMPs. Experience using single-use technologies and disposable systems. Ability to compute basic arithmetic operations: addition, subtraction, multiplication, and division. Physical Requirements Physical ability to walk and stand for extended periods of time. Frequently lift and or move objects up to 30 pounds. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus. $50,000 - $70,000 a year Values above to not include shift differentials FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
San Diego, CAManufacturing – Manufacturing /Full Time /On-Site With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Manager of Production Service will provide support to the Manufacturing Operations by leading the production services team in operational and continuous improvement activities. The focus of this position is to ensure facility cleaning is performed, materials are stock and staged for use in unit operations, solution formulations are manufactured and released for use in unit operations and startup / breakdown operations occur to maintain the production schedule, and monitoring operations occur during the off shift. Direct reports include Lead (Senior Production Service Associate) as well as Production Service Associates I & II Responsibilities Manage large volume liquid (buffer/media) manufacturing in support of Upstream Cell Culture and Downstream Purification operations Manage schedule use for production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Manage schedules to maintain daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Manage batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Manage, lead, mentor, and train all manufacturing employees in execution of buffer and media preparation. Manage and ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records. Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Oversee specifically assigned projects, to include monitoring project timelines, ordering supplies, and communication of project status to senior management. Network with MSAT, Manufacturing, and Quality organizations to establish a reliable state of process control Participate in technical transfer and implementation of media and buffer preparation strategies. Oversee activities involving buffer mixers, filtration systems, raw material management and intermediate solution delivery Draft, review and approve SOPs, master batch records, and other cGMP documentation Prepare technical reports, summaries, protocols, batch records and quantitative analyses as needed. Change owner for implementation or revision of equipment, documentation, and material specifications Propose implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success Develop effective working relationships with internal partners Represent departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups, as needed. Provide input and feedback on performance of production associates. Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena strategic goals Adhere and train staff on appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records. Forecast work scheduled activities in support of production schedules. Support floor operations for multiple projects simultaneously. Monitor processes and results and troubleshooting issues as they arise to ensure process success. Instruct associates through process and workflow improvement initiatives. Enforce cleanroom standards for cleanliness and order Review GMP records for completeness, accuracy, and compliance daily in conformance with regulatory requirements. May cross-train on various tasks supporting Upstream and Downstream cGMP manufacturing to support overall success of the Biologics group Operate to the highest ethical and moral standards Comply with Abzena's policies and procedures Communicate effectively with supervisors, colleagues and staff Participate effectively as a team player in all aspects of Abzena's business Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Perform other duties as assigned Qualifications BA/BS or MA/MS degree that included laboratory work in biology, microbiology, chemical engineering or related field. Minimum 6 years of experience in manufacturing operations, preferably in a GMP environment. Experience leading and developing associates, minimum 2 years of experience Experience organizing workload, oversee workload of direct reports, and relevant resource requirements. Experience in leadership duties, including time management and planning. Physical Requirements Physical ability to walk, stand and sit for extended periods of time. Ability to work in an office setting where sitting and computer usage would be the norm. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus $100,000 - $150,000 a year FLSA: Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
San Diego, CAManufacturing – Manufacturing /Full Time /On-Site With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Production Services Associate II is responsible for supporting both downstream and upstream production in a cGMP manufacturing environment. The Production Service team prepares buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down of operational equipment in accordance with the operations schedule. This role requires strict adherence to cGMP and standard operating procedures. Responsibilities Perform a variety of complex tasks in accordance with cGMP Operate and maintain production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Maintain/Perform daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Order, maintain, and stock supplies as directed (i.e. gowning, emergency kits, ect.) Documentation/verification of task completion in accordance with cGDP, SOPs and Batch Records. Monitor and maintain appropriate inventory levels of raw materials required for buffer and media prep. Manage a flexible work schedule where shift work may be required. Conduct activities in support of production schedules as directed by senior staff. Support floor operations for multiple projects simultaneously. Crosstrain on various tasks including Upstream/Downstream cGMP manufacturing. Operate in both a team and individual setting. Follow detailed instructions and maintain accurate records. Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique. Operate to the highest ethical and moral standards. Communicate effectively the status of floor operations to leads. Participate effectively as a team player in all aspects of Abzena's business. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Perform other duties as assigned. Qualifications 2-4 years of experience in cGMP manufacturing environment, preferably with buffer/media prep. A high school diploma is required. Technical degree in related field preferred. Knowledge and understanding of cGMPs. Experience using single-use technologies and disposable systems. Wear and maintain the required PPE to protect product integrity and ensure personal safety. Physical Requirements Physical ability to walk and stand for extended periods of time. Frequently lift and or move objects up to 30 pounds. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus. $70,000 - $90,000 a year Values above to not include shift differentials FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
San Diego, CAManufacturing – Manufacturing /Full Time /On-Site With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Senior Production Service Associate will primarily be responsible for organizing and leading production services and training associates involved in all aspects of production in a single use facility, including buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down operational equipment in accordance with the operations schedule Responsibilities Perform a variety of complex tasks in accordance with cGMP Operate/ maintain/ and schedule use for production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Schedule and maintain daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Provide hands-on training for staff to ensure compliance with training on all activities prior to GMP execution. Ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records. Schedule day-to-day work scheduled activities in support of production schedules. Support floor operations for multiple projects simultaneously. Competent in Upstream and Downstream Operations Provide cross train on various tasks including Upstream/Downstream cGMP manufacturing. Adhere and train staff on appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique Monitor processes and results and troubleshooting issues as they arise to ensure process success. Provide detailed observations, analyze data and interpret results. Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. Guide associates through process and workflow improvement initiatives. Enforce cleanroom standards for cleanliness and order Communicate effectively with supervisors, colleagues, and staff to provide status of floor operation to management on a regular basis. Direct floor operations for multiple projects simultaneously. Adjust as necessary to adhere to production schedules. Review GMP records for completeness, accuracy, and compliance daily in conformance with regulatory requirements. Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. Identify and initiate deviations, assist in assessing product quality impact, and assisting with proposals for Corrective and Preventative Actions (CAPA). Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including weekend work, as needed. Perform additional duties as assigned. Qualifications BA/BS degree in chemistry, biology, or related field. At least 4 – 5 years of experience in a GMP pharmaceutical/biotech environment role. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Skilled with using single-use technologies Strong technical and mechanical aptitude in bioprocessing. Knowledge of upstream and/or downstream operations. Experience leading, training, and coaching peers. Computer proficiency A proven ability to confidently compute basic arithmetic operations. Physical Requirements Physical ability to walk, stand and sit for extended periods of time. Frequently lift and or move objects at least 30 pounds in weight. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus. $90,000 - $110,000 a year Values above to not include shift differentials FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
Quality Assurance Associate, Clinical Supplies Position Summary: Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. Catalent Pharma Solutions in San Diego, CA is hiring a Quality Assurance (QA) Associate for our Clinical Supplies team. Under general supervision, the QA Associate performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. This individual follows established protocols and work plans, and may be assisted by QA Specialists and Sr. Specialists. This role is essential to comply with divisional and site Environmental Health and Safety (EHS) requirements. This is a full-time hourly position on-site: Monday-Friday on 1st shift (day shift). Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Responsible for inspection of incoming materials for GMP production. Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.) Reviews production batch records, logbooks and other associated documents. Performs Quality verification of just-in-time labeling activities Performs document issuance, scanning, filing and archival activities. Revises SOPs, Work Instructions and Forms pertaining to their area of focus, as needed. Assists in the execution of efficiency improvement projects with guidance Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs Participates in Quality programs, procedures and controls to ensure that products conform to established standards and agency guidelines. Ensures gathering of data, investigations and deviations are timely and compliant Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines Respond and interact with internal and external clients in a professional and timely manner Other duties as assigned. The Candidate: Associate’s Degree or equivalent knowledge and experience is required. Lean Six Sigma or ASQ Certification is preferred Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form. Must be able to use existing procedures to solve routine and non-routine problems Must be able to utilize all elements of the quality system to identify, classify and control the status of incoming materials Recognizes unmet needs within department and business Mathematical and scientific reasoning ability. Ability to identify aberrant data and potential quality/compliance concerns escalating to management Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently Pay: The anticipated starting salary range for this role in San Diego, CA is $56,000 to $61,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Several Employee Resource Groups focusing on Diversity and Inclusion. Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 152 hours of PTO + 10 paid holidays. Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Tuition Reimbursement – Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. JOB DESCRIPTION: Position Title: Manager, Quality Control Location: San Diego, CA Department: Quality – Inspection The Manager of Quality Control oversees Quality Control in production and warehouse areas. The Manager of Quality Control will also provide support for investigations, complaints, CAPAs, inspections, product / material release, document control, quality metrics, audits, and continuous improvements. ESSENTIAL DUTIES AND RESPONSIBILITIES: Implement, monitor, and audit corrective actions Direct oversight of Quality Control for site Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules Complete complaint investigations Complete internal investigations Monitor and improve Internal Batch Record Right First Time Provide hands-on training for staff Collect quality metrics and make recommendations for continuous improvement Implement, improve, and maintain systems and processes for Quality Control Conduct and/or support internal, supplier, regulatory and customer audits May perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor May perform QC inspection or release of incoming GMP materials according to appropriate material specifications Perform NMR investigations Ensure department and company goals are met Performs other duties as assigned QUALIFICATIONS: Required: High School Diploma and/or 3-5 years related experience and/or training. Basic Mathematical Skills Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. The base salary hiring range for this position is ($95,360 - $107,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-AK2 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Our dynamic California based company has been providing quality survey and mapping services to utility and telecommunication companies for over 12 years and our Temecula office is looking to add professionally minded individuals to our team. An immediate opening is available for a an entry-level to experienced Drafter. If you are experienced in the below duties, we would really like to talk to you! *Position Description* The CAD Technician (Drafter) will contribute to the production of planner redlines, base maps, exhibits, profiles, elevations, and other land surveying and civil engineering work as related to base mapping. *Essential Functions* * Produce preliminary base maps, to include: interpretation of wet and dry utilities, profiles, details, elevations, coordinates, exhibits, and vicinity maps * Comprehension and analysis of public right-of-ways, private easements, underground and aerial utilities * General knowledge and familiarity of underground utilities, civil engineering practices, and basic survey field processes * Perform assigned responsibilities with moderate supervision * Adhere to drafting standards * Ensure all work is routinely backed up and archived * Ability to work independently and stay on task * Ability to hit deadlines * Accurate and detailed oriented * Excellent communication and consistently available during working hours. * Other duties as assigned *Essential Skills/Qualifications* * Proficiency using AutoCAD drafting software, Civil 3D experience a plus * Strong knowledge of Microsoft Office Suite; Microsoft Access experience a plus * Ability to meet competing deadlines * Organize, prioritize, and perform multiple tasks and projects simultaneously *Physical Demands and Work Environment* * Frequently required to utilize hand and finger dexterity for company equipment * While performing the duties of this job, the noise level in the work environment is usually quiet to moderate as this may be a remote position. * The employee must occasionally lift and/or move more than 10 pounds * Specific vision abilities required by this job include: close vision, Distance vision, Color vision, Peripheral vision, Depth perception and ability to adjust focus * This job operates in a professional office or home office environment. This role routinely uses standard office equipment such as desktop computers and photocopiers *The Hired Candidate Will Enjoy:* * Health, dental, and vision insurance * Life Insurance * 401K retirement options * Paid Time Off * Beautiful office space * Fantastic team and room for growth If you are looking to join a great team that is growing, then apply today! *WE ARE A DRUG FREE WORKPLACE.* Job Type: Full-time Pay: $24.00 - $34.00 per hour Benefits: * 401(k) * Dental insurance * Flexible spending account * Health insurance * Life insurance * Paid time off * Retirement plan * Vision insurance Work Location: In person
Introduction THE CITY OF OCEANSIDE IS AN EQUAL OPPORTUNITY EMPLOYER. The City of Oceanside is accepting applications for Maintenance Worker III. There is currently one vacancy in the Building Maintenance Division of the Public Works Department. HVAC experience is highly desirable. Examples of Duties The Maintenance Worker III oversees and participates in the more complex work of staff responsible for the maintenance, repair, and construction of various City facilities and structures including streets, signs, parks, roadsides, medians, water or sewer systems, docks and piers; installs and repairs water mains, lateral and transit water lines, and fire hydrants; tests new water lines; reads and interprets construction plans; installs sewer lines; installs 5/8" to 10" water meters; builds underground water meter vaults; operates a variety of tapping machines to make ¾" to 12" hot taps; performs skilled repairs to structures including plumbing, electrical, painting and carpentry work; directs and controls traffic; ensures proper traffic control is set up; oversees and performs street cuts for excavation and replacement of new asphalt; removes and replaces concrete and asphalt; mixes, rakes and spreads asphalt; seals cracks and patches streets; performs pot hole patching and surface repairs; constructs forms; mixes and pours cement; finishes cement on curbs, gutters and sidewalks; designs and lays out street and intersection markings for painting; paints and stripes streets, curbs and parking lots; installs raised pavement markers; removes painted lines from streets; lays out construction of curbs, sidewalks and gutters; monitors and maintains roadways by removing sand, gravel and debris from streets; maintains parks, parkways, athletic fields, and medians; assembles, inspects, maintains and repairs playground equipment; builds and installs fences; operates gas torch to cut and weld metal; provides direction in irrigation systems projects; inspects and monitors operations of the irrigation systems; installs, maintains and repairs pipes valves and timers; programs controllers or timers; troubleshoots electrical problems; ensures systems operate efficiently and effectively; directs crews and participates in pruning trees and shrubs; removes tree stumps and roots; calculates amount of chemical needed for weed and pest control; applies pesticides, herbicides and fertilizes grounds; maintains pertinent records; performs building maintenance and construction functions including new construction, framing, drywall and painting; oversees others and repairs pier decking and docks; replaces piling caps and cross beams; diagnoses electrical failures in lighting fixtures and repairs them; installs conduits for electrical services; operates a variety of construction and maintenance equipment and power tools such as dump trucks, ten-wheelers, tractors, front end loaders, skip loaders, aerial boom trucks, backhoes, grader, paving machine, compressor, jack hammer, paint sprayer, sand-blaster, and concrete saw; reports needed mechanical repairs to supervisor; hauls equipment and materials to and from sites; installs, repairs and replaces street signs and posts; cleans and maintains existing signs; removes graffiti from City property; operates a street sweeper to clean streets and parking lots; maintains assigned vehicle; inspects vehicle to ensure safe operating condition; performs preventive maintenance on tools and equipment; maintains inventory of parts and supplies; cleans and maintains maintenance shop, tools, work space and equipment; responds to emergencies as needed; may perform after hours stand-by duties. Minimum Qualifications Knowledge of: Advanced methods and techniques of maintenance, construction and repair related to the area of work assigned. Principles of lead supervision and training. Operational characteristics of equipment and tools used in the area of work assigned. Methods and techniques of concrete finishing and repair. Methods and techniques of street maintenance, repair and asphalt overlay. Techniques of street striping and sign installation. Techniques of carpentry, plumbing, painting, welding, and electrical maintenance and repair. Methods and techniques of irrigation systems design, installation and maintenance. Operational characteristics of water distribution and sewer systems. Tree care, pruning and maintenance. Geographic characteristics and street layout of the City. Principles and practices of maintenance and repair of assigned equipment. Occupational hazards and standard safety practices. Pertinent Federal, State and local laws, codes and regulations. Ability to: Oversee and participate in a variety of maintenance, construction and repair work in the area of work assigned. Lead, organize and review the work of staff. Perform heavy manual labor. Use and operate a variety of maintenance and repair equipment in a safe and effective manner. Operate assigned street sweeping vehicle. Read and understand street maps. Perform preventive maintenance on assigned equipment and tools. Clean, maintain and repair assigned tools and equipment. Work independently in the absence of supervision. Communicate clearly and concisely, both orally and in writing. Understand and carry out oral and written instructions. Establish and maintain effective relationships with those contacted in the course of work. Experience and Training Experience: Three years of increasingly responsible maintenance, construction or repair experience. HVAC experience is highly desirable. Training: Equivalent to the completion of the twelfth grade. License, Certificate: Possession of an appropriate, valid driver's license. Working Conditions and Selection Process Environmental Conditions: Field environment, travel from site to site; exposure to noise, dust, grease, smoke, fumes, gases, inclement weather conditions, potentially hazardous chemicals or waste and infectious materials; work in or with water; work at heights on scaffolding and ladders; work in confined spaces, underground, on slippery or uneven surfaces and around heavy equipment. Physical Conditions: Essential functions may require maintaining physical condition necessary for standing, walking, sitting, bending, or kneeling for prolonged periods of time; heavy, moderate or light lifting and carrying; pulling, pushing, reaching; operating motorized vehicles and equipment. Selection Process: All properly completed applications will be reviewed and the most appropriately qualified individuals will be invited to continue in the selection process. The process may include any combination of a written exam, oral board exam, and/or skills assessment to further evaluate job-related qualifications. Candidates who successfully complete the examination process will be placed on the Eligibility List according to their scores and will remain eligible for employment consideration for a minimum of one year. RESUMES WILL NOT BE ACCEPTED IN LIEU OF COMPLETED APPLICATION FORMS BUT MAY BE ATTACHED. CANDIDATES WHO REQUIRE A REASONABLE ACCOMMODATION IN THE SELECTION PROCESS SHOULD STATE THEIR NEEDS IN WRITING WHEN SUBMITTING AN APPLICATION. THE PROVISIONS OF THIS BULLETIN DO NOT CONSTITUTE AN EXPRESSED OR IMPLIED CONTRACT. ANY PROVISION CONTAINED IN THIS BULLETIN MAY BE MODIFIED OR REVOKED WITHOUT NOTICE.