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Director, CMC Analytical Development
146630
Posted:
07th
October 2024
- 200000 USD - 245000 USD
- Redwood City, United States
- Permanent
Meet is partnered with a clinical-stage biopharmaceutical company dedicated to developing novel therapeutics for the treatment of rare diseases. They are currently seeking a Director, CMC Analytical Development to join our team. In this pivotal role, you will lead our analytical development function, ensuring the highest standards of quality and regulatory compliance for our drug substance and drug product activities.
Responsibilities:
- Develop and implement comprehensive CMC analytical strategies to support drug development and regulatory submissions.
- Collaborate closely with VP, CMC to align analytical activities with company goals and regulatory requirements.
- Lead the development, validation, and implementation of analytical methods for drug substances and drug products.
- Ensure integrity, accuracy, and compliance of analytical data in accordance with FDA, EMA, and other regulatory standards.
- Prepare and review CMC analytical sections of regulatory submissions (IND, BLA, NDA, MAA) and respond to regulatory requests for information.
- Represent the company in regulatory interactions and inspections related to analytical activities.
- Manage analytical project timelines, budgets, and resources to ensure on-time milestone delivery.
- Coordinate with cross-functional teams (R&D, quality, regulatory, clinical) to support CMC analytical activities.
- Stay abreast of advancements in analytical technologies and implement new technologies to enhance capabilities and efficiencies.
- Perform other duties as assigned.
Qualifications:
- Master’s degree or Ph.D. in chemical engineering, chemistry, organic chemistry, or related scientific discipline.
- 7-10 years of experience in CMC analytical development, focusing on small molecule therapeutics; expertise in modified-release products preferred.
- Extensive experience managing US CRO/CMOs for analytical activities related to cGMP drug substances and drug products; international CRO/CMO collaboration experience is a plus.
- Strong knowledge of GMP quality systems and regulatory requirements for drug development.
- Proven leadership skills with excellent organizational, communication, and interpersonal abilities.
- Ability to thrive in a fast-paced, dynamic environment and willingness to travel as needed.
Leila Johnston
Division Director