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Senior Scientist II Analytical Development CMC
150402
Posted:
17/09/2024th
17/09/2024
- 160000 USD - 160000 USD
- South San Francisco, United States
- Permanent
.Meet is partnered with an exciting Bay Area Biotech on a Senior Scientist, Analytical Development opportunity!
Our client is looking for a candidate with an expertise in small molecule analytical development of drug substances and drug products with strong CMC experience and CMO oversight of outsourced to advance drug candidates through clinical phases to commercialize a product.
This is an exciting opportunity to join a leading biotech in South San Francisco with an active clinical and pre-clinical pipeline in immunological diseases. They are a well funded organization with an amazing culture and competitive benefits.
Responsibilities:
- Manage in-house and outsourced CMC development activities with minimal guidance (e.g., method development, transfers, validations, material management, release/stability testing).
- Perform hands-on analytical lab work, including method development, troubleshooting, and testing for clinical projects.
- Characterize drug impurities, degradation products, and other properties.
- Review and approve CMO/CTL analytical data, ensuring accuracy and completion.
- Track and analyze release/stability data and prepare reports.
- Collaborate with cross-functional teams to meet project timelines.
- Write and review technical documents (e.g., method protocols, release reports, stability protocols).
- Ensure compliance with ICH, EMA, and pharmacopeia standards.
- Assist in preparing CMC documents for regulatory submissions.
Ideal Candidate:
- PhD/MS in chemistry or pharmaceutical sciences.
- Expertise in small molecule analytical techniques (e.g., UPLC/HPLC, LC-MS, GC, UV/Vis).
- Experience with GMP batch release and stability data.
- Self-motivated, organized, and collaborative.
- Strong knowledge of ICH, cGMP, and regulatory requirements.
- Experience with immediate/modified-release formulations.
- Skilled in data interpretation, mentoring, and resource management.
- Ability to influence and contribute strategically at the team level.
Martin Wenzel
Division Director