Senior Manager, Analytical Development and Quality Assurance
3 weeks ago
Pliant Therapeutics is a leading biopharmaceutical company dedicated to the discovery and development of innovative therapies for fibrotic diseases. As a key member of our Chemistry, Manufacturing, and Controls (CMC) team, you will play a critical role in driving the development of our pipeline.
Key Responsibilities- Method Development and Validation: Manage the development, qualification, and validation of analytical methods at contract laboratories, ensuring compliance with regulatory requirements.
- Contract Laboratory Management: Oversee the management of contract testing laboratories, including review of analytical data, provision of feedback, and resolution of technical or quality issues.
- CMO/CRO Management: Manage the testing activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) for all analytical development and quality control activities.
- Collaboration and Communication: Collaborate with other members of the CMC team to ensure timely release of clinical products and resolution of product investigations, as well as author and review technical reports, deviations, and change control documents.
- Regulatory Support: Summarize experimental findings, review, and interpret development and stability study results, and assemble analytical data packages to support regulatory submissions.
- Sample Management: Manage sample inventory and support miscellaneous activities, such as shipping.
- Education: B.S. in Chemistry or relevant technical field, advanced degree preferred.
- Experience: A minimum of 8 years' experience in analytical development of new chemical entities in the pharmaceutical industry, including managing methods development, validation, and testing at contract testing laboratories.
- Skills: Comprehensive working knowledge of GLPs and GMPs as they relate to drug development and analytical testing, excellent written and verbal communication skills, and organizational skills as well as ability to prioritize and manage multiple tasks under tight timelines.
- Collaboration: Ability to engage collaboratively with CMC functions, with other functions within Pliant, and with external testing laboratories.
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South San Francisco, California, United States Pliant Therapeutics Full time{"title": "Senior Manager, Analytical Development and Quality Control", "description": "Job SummaryPliant Therapeutics is a leading biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. As a Senior Manager, Analytical Development and Quality Control, you will play a critical role in the development and...
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South San Francisco, California, United States Pliant Therapeutics Full timeAbout Pliant TherapeuticsPliant Therapeutics is a late-stage biopharmaceutical company dedicated to discovering and developing novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is committed to addressing the unmet medical needs of physicians, patients, and families affected by fibrotic...
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South San Francisco, California, United States Pliant Therapeutics Full timeAbout the RolePliant Therapeutics is a leading biopharmaceutical company dedicated to the discovery and development of innovative therapies for fibrotic diseases. As a key member of our Chemistry, Manufacturing, and Controls (CMC) team, you will play a critical role in driving the development of our pipeline.Key ResponsibilitiesMethod Development and...
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