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Senior Manager, Analytical Development and Quality Assurance
2 months 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.
- CMO/CRO Management: Oversee the management of contract manufacturing organizations (CMOs) and contract research organizations (CROs) for all analytical development and quality control activities.
- Contract Laboratory Management: Assist in the selection and management of contract laboratories, ensuring timely and high-quality results.
- Collaboration and Communication: Collaborate with cross-functional teams to ensure timely release of clinical products and resolution of product investigations.
- Technical Reporting: Author and review technical reports, deviations, and change control documents, summarizing experimental findings and interpreting development and stability study results.
- Education: B.S. in Chemistry or relevant technical field, advanced degree preferred.
- Experience: 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, excellent written and verbal communication skills, and organizational skills with the ability to prioritize and manage multiple tasks under tight timelines.
