Senior CMC Leader for Biotech and Gene Therapy
3 weeks ago
Are you a seasoned professional seeking a challenging role in the biotech industry? We are currently looking for a Senior CMC Leader to join our team at EPM Scientific, a top 10 pharmaceutical company. This position offers an exceptional opportunity to lead cross-functional teams and contribute to the development of cutting-edge therapies.
About the RoleWe are seeking a highly experienced CMC professional with a strong background in gene therapy and biologics. As a Senior CMC Leader, you will be responsible for managing the development and manufacturing of drug substances and drug products. Your expertise will play a critical role in ensuring the quality and regulatory compliance of our products.
Key Responsibilities- Design, develop, and validate analytical methodologies for our pipeline.
- Identify opportunities to improve productivity and efficiency in projects and analytical science.
- Collaborate with diverse teams, including CDMO analytical science teams.
- Lead analytical science in project teams, ensuring alignment and fostering productive relationships with other core functions.
- Ensure data integrity and promote knowledge sharing throughout the medicine development lifecycle.
- Ensure compliance with regulatory standards including GMP, ICH, EMA, and FDA guidelines.
The ideal candidate will have a minimum of 10 years of experience in biotech for large and small molecules (Director) or 8 years of experience (Associate Director). You will also possess a Master's Degree in a relevant scientific discipline and strong process understanding in one or more of the following areas: biologics, oligonucleotide, cell therapy, viral vectors, gene therapy, or LNP.
What We Offer- A competitive base salary range of $170,000 - $215,000.
- Unlimited vacation and generous sick time.
- Company-sponsored meals and snacks.
- Wellness, caregiver, and ergonomics benefits.
- 401(k) with company matching.
We offer a dynamic work environment and the opportunity to work on groundbreaking projects. If you are a motivated and results-driven professional looking for a new challenge, we encourage you to apply.
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