Associate Director, Quality Control, Reference Standards
4 weeks ago
Vaxcyte is seeking a highly experienced Associate Director to lead the quality control team in managing reference standards and critical reagents. The successful candidate will be responsible for developing and implementing policies, procedures, and strategies for Vaxcyte's global reference standard and critical reagent management systems.
The ideal candidate will have a strong understanding of cGMP, FDA, EU, and ICH regulatory guidance associated with release and characterization assays. They will also have experience with LIMS, analytical statistics, and statistical software, as well as strong biostatistics background for evaluating comparability and qualification of reference standards.
The Associate Director will lead the development of global business practices, policies, and standards for reference standards and critical reagents, including qualification/requalification, resupply, and inventory management. They will also be responsible for reviewing and managing OOS/OOT and deviations, and developing strategies and decisions in risk mitigation around reference standards and critical reagents.
The successful candidate will have a Ph.D. with 8+ years of AD/QC experience or MS/BS with 12+ years of AD/QC experience, including 5+ years in reference standard management within the vaccine, biotech, or pharma industry. They will also have strong written and verbal communication skills, and the ability to work globally with external suppliers in a team-oriented environment under dynamic conditions.
Vaxcyte is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
-
San Carlos, California, United States BioSpace, Inc. Full timeVaxcyte is a clinical-stage vaccine innovation company that engineers high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.We bring creative and intellectual diversity to every facet of our work to innovate and re-innovate the way vaccines are...
-
San Carlos, California, United States BioSpace, Inc. Full timeJob SummaryVaxcyte seeks an experienced Associate Director to lead the Quality Control team in managing reference standards and critical reagents. The successful candidate will develop and implement policies, procedures, and strategies for global reference standard and critical reagent management systems.Key ResponsibilitiesDevelop and implement policies,...
-
Associate Director, Quality Control Lead
4 weeks ago
San Diego, California, United States Avidity NanoMedicines Full timeJob Title: Associate Director, Quality ControlAt Avidity Biosciences, we are seeking an experienced Associate Director, Quality Control to lead all Quality Control aspects for GMP Operations in all phases of product development.Key Responsibilities:Establish and drive strategy to ensure compliance with phase-appropriate Quality Control requirements at...
-
San Francisco, California, United States BioSpace, Inc. Full timeNurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders.Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix...
-
Quality Control Specialist
4 weeks ago
San Carlos, California, United States Sutro Biopharma Full timeQuality Control SpecialistSutro Biopharma, Inc. is seeking a highly skilled Quality Control Specialist to join its team in San Carlos, CA. As a key member of the Quality Control group, you will play a critical role in ensuring the quality and safety of our products.Responsibilities:Support QC testing in-process, release, and stability testing on a routine...
-
Senior Quality Control Director
4 weeks ago
San Diego, California, United States Avidity Biosciences, Inc. Full timeJob Title: Associate Director, Quality ControlLocation: Hybrid - San Diego and RemotePosition type: FLSA: Full time ExemptDepartment: Finance ID: Technical Development & Operations (TD&O)About the RoleThe Associate Director, Quality Control will lead all Quality Control aspects for GMP Operations in all phases of product development. This role will be...
-
Senior Quality Control Director
4 weeks ago
San Diego, California, United States Avidity Biosciences, Inc. Full timeJob Title: Associate Director, Quality ControlJob Summary:The Associate Director, Quality Control will lead all Quality Control aspects for GMP Operations in all phases of product development. This role will develop systems and procedures, build relationships with our CMO/CTO network, and serve as a subject matter expert (SME) for analytical and microbiology...
-
San Francisco, California, United States BioSpace, Inc. Full timeJob OverviewNurix Therapeutics, a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies, is seeking an experienced Senior Manager/Associate Director to join its CMC Analytical Development and Quality Control group. The ideal candidate will oversee and execute analytical development, tech transfer,...
-
Director of Quality Control
4 weeks ago
San Diego, California, United States BioSpace, Inc. Full timeJob DescriptionFate Therapeutics, Inc. is seeking a highly motivated professional to support its cellular therapy programs in the role of Director / Associate Director, Quality Control.The successful candidate will have experience participating in and leading high-performing teams executing analytical test methods in a QC operations environment, working with...
-
Quality Control Manager
1 month ago
San Carlos, California, United States Vaxcyte Full timeProtect Humankind from Bacterial DiseasesVaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines to safeguard humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. We are...
-
San Francisco, California, United States BioSpace, Inc. Full timeJob SummaryNurix Therapeutics is seeking an experienced Senior Manager/Associate Director to join the CMC Analytical Development and Quality Control group. The ideal candidate will oversee and execute analytical development, tech transfer, and testing operations internally and at external CDMO/CRO partners.Key ResponsibilitiesIndependent management of key...
-
Director of Quality Control
4 weeks ago
San Diego, California, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly motivated Director of Quality Control to join our team at BioSpace, Inc. This role will be responsible for providing oversight and support for execution, optimization, transfer, qualification, and validation of analytical methods supporting manufacturing in-process control (IPC) and lot release of product, within a Good...
-
San Mateo, California, United States GILEAD Sciences Full timeJob SummaryGilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for over three decades. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. As a Senior Associate Scientist, Biologics Quality Control, you will play...
-
Clinical Outsourcing Associate Director
4 weeks ago
San Carlos, California, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced Clinical Outsourcing Associate Director to support our clinical development program. The successful candidate will oversee and manage all clinical trial contracts from study start-up through to study closeout, collaborating closely with clinical management on long-range plans and supporting clinical teams on...
-
Senior Quality Control Associate
1 month ago
San Diego, California, United States Wacker Chemie AG Full timeJob SummaryWe are seeking a highly experienced Senior Quality Control Associate to join our team in San Diego. The successful candidate will be responsible for leading project groups, managing project schedules, and collaborating with Operations, Process Development, and external clients. The ideal candidate will have a strong background in analytical...
-
Supervisor, Quality Control Reagent
4 weeks ago
San Carlos, California, United States Natera Full timeJob SummaryThe Supervisor, QC Reagent will oversee the day-to-day operations of manufacturing and testing of consumable reagents to support production. This role works closely with the Manager to ensure company and team goals are met, with a focus on ensuring quality work is completed timely.Key Responsibilities Provide direct supervision and follow-up to...
-
Senior Quality Control Associate
4 weeks ago
San Diego, California, United States Wacker Chemie AG Full timeAre you a seasoned analytical expert looking to take on a leadership role in a dynamic team? Wacker Chemie AG is seeking a Senior Quality Control Associate - Analytical to join our San Diego team. In this role, you will lead method transfer, development, and qualification projects, working closely with our QC control team, Process Development Team, and...
-
Supervisor, Quality Control Reagent
1 month ago
San Carlos, California, United States Natera Full timeJob SummaryThe Supervisor, QC Reagent will oversee the day-to-day operations of manufacturing and testing of consumable reagents to support production. This role will work closely with the Manager to ensure company and team goals are met, ensuring quality work is completed timely.Key ResponsibilitiesProvide direct supervision and follow-up to individual...
-
Biologics Quality Control Associate
4 weeks ago
San Mateo, California, United States Gilead Sciences Full timeAbout Gilead SciencesGilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for over three decades. Our mission is to create a healthier world for all people by advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.Job SummaryWe are...
-
San Carlos, California, United States BioSpace, Inc. Full timeJob SummaryThe Sr. Quality Assurance Specialist, External Manufacturing will play a pivotal role in ensuring that all external batch records adhere to Vaxcyte's quality standards and regulatory requirements.Key ResponsibilitiesBatch Record Review: Reviewing executed batch records, resolving discrepancies, and effectively working with cross-functional...