Senior Manager, Analytical Sciences Expert
7 days 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 Out-of-Specification (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.
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