Current jobs related to Analytical Sciences Leadership Position - Brisbane, California - Vera Therapeutics
-
Senior Manager, Analytical Sciences Expert
4 weeks ago
Brisbane, California, United States Vera Therapeutics Full timeAbout Vera TherapeuticsVera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.Job SummaryWe are seeking a Senior Manager, Analytical Sciences to join our...
-
Clinical Science Lead
4 weeks ago
Brisbane, California, United States Bristol Myers Squibb Full timeJob SummaryBristol Myers Squibb is seeking a highly skilled Clinical Science Lead to join our team. As a key member of our Clinical Science function, you will be responsible for leading the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team.Key ResponsibilitiesLead the Clinical Science...
-
Senior Director of Analytical Development
6 days ago
Brisbane, California, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled Associate Director to join our team at BioSpace, Inc. as a key player in our product development teams. The successful candidate will be involved in managing a network of Contract Development and Manufacturing Organizations (CDMOs) for Drug substance and Drug Product manufacturing for our pipeline.Key...
-
Senior Analytics Engineer
2 weeks ago
Brisbane, California, United States Heirloom Carbon Full timeAbout UsWe're a team of passionate individuals working together to slow climate change. Our mission is to remove 1 billion tons of CO2 from the sky by 2035, and we're united behind a single goal - to make low-cost, high-quality carbon removal a reality.We're a diverse company that values radical honesty, persistent optimism, and a growth mindset. We believe...
-
Clinical Scientist Lead
1 week ago
Brisbane, California, United States Bristol-Myers Squibb Full timeTransforming Patients' Lives Through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Clinical Scientist Lead to join our team and contribute to the design and delivery of clinical studies and programs.Key ResponsibilitiesLead the Clinical Science team...
-
Associate Director
2 weeks ago
Brisbane, California, United States Mammoth Biosciences Full timeJob SummaryMammoth Biosciences is seeking a highly experienced Associate Director to lead our CMC development efforts. As a key member of our product development teams, you will be responsible for managing a network of CDMOs for drug substance and drug product manufacturing. Your expertise in analytical development and manufacturing strategies will be...
-
Corporate Controller
1 week ago
Brisbane, California, United States Freenome Full timeAbout this Opportunity: Freenome is seeking a highly skilled Corporate Controller to lead the accounting department and drive financial excellence. As a key member of the finance team, you will be responsible for building scalable accounting processes, ensuring timely and accurate financial reporting, and maintaining strong internal controls. This is a...
-
Clinical Scientist Lead
2 weeks ago
Brisbane, California, United States Caliber Sourcing Full timeJob Title: Clinical Scientist LeadJoin Caliber Sourcing in a challenging and rewarding role as a Clinical Scientist Lead. In this position, you will be responsible for leading a team of clinical scientists in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team.Key...
-
Corporate Communications Director
6 days ago
Brisbane, California, United States Freenome Full timeAbout FreenomeFreenome is a pioneering biotech company dedicated to revolutionizing cancer detection through innovative tests. Our multiomics platform combines tumor and non-tumor signals with machine learning to identify cancer in its earliest stages. This groundbreaking approach has the potential to save lives and improve patient outcomes.We are seeking a...
-
Clinical Scientist Lead
2 weeks ago
Brisbane, California, United States Caliber Sourcing Full timeJob DescriptionBristol Myers Squibb is a leading pharmaceutical company that is committed to transforming patients' lives through science. We are seeking a highly skilled and experienced Clinical Scientist Lead to join our team.Key ResponsibilitiesLead the Clinical Science team in the planning and execution of clinical trial activities to support the...
-
Associate Director
1 month ago
Brisbane, California, United States Mammoth Biosciences Full timeJob SummaryMammoth Biosciences is seeking a highly experienced and skilled professional to join our team as an Associate Director / Director, CMC. This role will be responsible for providing support across all developmental and clinical programs, managing a network of CDMOs for Drug substance and Drug Product manufacturing, and ensuring compliance with...
-
Manager/Senior Manager, CMC Quality Control
15 hours ago
Brisbane, California, United States Innova Solutions Full timeJob Summary: Innova Solutions is seeking a highly motivated and experienced professional as Manager/Senior Manager for our clinical and commercial programs in the CMC Quality Control Department. The successful candidate will have a good understanding of analytical and biological methodologies, cGMPs, ICH guidelines, Regulatory drug requirements, and be a...
-
Senior Manager, CMC Quality Control Specialist
4 weeks ago
Brisbane, California, United States Beacon Hill Full timeJob Title: Senior Manager, CMC Quality Control Writer and ReviewerBeacon Hill is seeking a highly motivated and experienced professional as Senior Manager for CMC Quality Control department, with the passion and creativity to support development of great medicines for rare and ultra-rare diseases.Job Summary:The Senior Manager will be responsible for all...
-
Associate Director
4 weeks ago
Brisbane, California, United States BioSpace, Inc. Full timeJob DetailsOpportunityMammoth Biosciences is seeking a highly skilled professional to join our team as an Associate Director/Director, CMC. This individual will play a key role in our product development teams, providing support across all developmental and clinical programs. The successful candidate will be responsible for managing a network of CDMOs for...
-
Associate Director
1 month ago
Brisbane, California, United States Mammoth Biosciences Full timeJob Title: Associate DirectorMammoth Biosciences is seeking an experienced Associate Director to join our team. As a key member of our product development teams, you will provide support across all developmental and clinical programs. Your expertise in managing a network of Contract Development and Manufacturing Organizations (CDMOs) for Drug substance and...
-
Associate Director CMC
2 weeks ago
Brisbane, California, United States BioSpace, Inc. Full timeJob DetailsOPPORTUNITYMammoth Biosciences is seeking a highly skilled and experienced professional to join our team as an Associate Director / Director, CMC. This is a key role in our product development teams, providing support across all developmental and clinical programs. The successful candidate will be involved in managing a network of CDMOs for Drug...
-
Senior Manager, CMC Quality Control
2 weeks ago
Brisbane, California, United States Innova Solutions Full timeJob Title: Senior Manager, CMC Quality ControlInnova Solutions is seeking a highly motivated and experienced professional to lead our CMC Quality Control team. As a Senior Manager, CMC Quality Control, you will be responsible for reviewing release and stability data, managing method development and validation, and providing quality control operational...
-
Process Development Engineer II
4 weeks ago
Brisbane, California, United States CareDx, Inc. Full timeJob Title: Process Development Engineer IICareDx, Inc. is seeking a highly motivated and independent Process Development Engineer II to monitor and improve a diverse collection of CLIA and manufacturing processes. These include the processing of patient samples through various workflows in a CLIA-certified laboratory to Formulation, QC and Filling processes...
-
Process Development Engineer II
4 weeks ago
Brisbane, California, United States CareDx, Inc. Full timeJob Title: Process Development Engineer IICareDx, Inc. is seeking a highly motivated and independent Process Development Engineer II to monitor and improve a diverse collection of CLIA and manufacturing processes. These include the processing of patient samples through various workflows in a CLIA-certified laboratory to Formulation, QC and Filling processes...
-
Vice President of Commercial Operations
2 weeks ago
Brisbane, California, United States Annexon Bioscience Full timeJob Title: Vice President, Commercial OperationsAt Annexon Biosciences, we are seeking a highly experienced and strategic leader to join our commercial operations team as Vice President, Commercial Operations. This role will be responsible for leading all aspects of commercial operations to support the successful launch and commercialization of our...
Analytical Sciences Leadership Position
2 months ago
Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
Job SummaryWe are seeking a Senior Manager, Analytical Sciences to join our experienced, fast-paced and collaborative team. The Senior Manager, Analytical Sciences will report to the Associate Director, Analytical Sciences (Quality Control) and will manage method validation, method transfer, and stability programs.
Key Responsibilities- Develop, transfer, qualify and validate analytical methods used for in-process testing, drug substance and drug product release, demonstration of comparability, and stability testing.
- Manage data and associated activities for method transfer, validation, batch release, and stability for in-process, drug substance, and drug product at Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs).
- Maintain Reference Standards and critical reagents for multiple CMOs and third-party testing sites.
- Review CMO and third-party qualification/validation protocols, test procedures, raw data, and technical reports.
- Author technical protocols, reports, and analytical sections for regulatory filings.
- Contribute to due diligence activities, gap analysis, deviations, and OOS investigations.
- Master's or Bachelor's degree in Chemistry, Biochemistry, or related discipline with a minimum of 6 years of experience in clinical-stage biopharma with a proven technical track record in Quality Control.
- Experience developing, implementing, or supporting analytical methods for release, stability, and extended characterization testing across multiple technical areas (chromatography, bioassays, spectroscopy, etc.).
- Experience managing large analytical data sets including method transfer, method validation, lot release, and stability data.
- Experience managing critical reagents.
- Familiarity with international regulatory guidelines for analytical methods.
- Experience authoring and reviewing analytical methods, technical reports, and regulatory filings.
- Experience working with CDMOs and third-party testing sites.
- Experience with statistical analysis and statistical software is a plus.
- Excellent interpersonal skills and demonstrated ability to work well in a team-oriented environment.
Vera Therapeutics is an equal-opportunity employer. We offer a competitive total compensation package, including an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. We also offer various benefits, including medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
