Vice President CMC - Pharma-Cruiting - Life Sciences Executive Recruiters

Position Description

We are seeking a Vice President of Chemistry, Manufacturing and Control (CMC) for our biopharmaceutical client in Massachusetts.

The incumbent will be an integral part of a cross‐functional R&D team responsible for progressing the company’s development portfolio consisting of a novel class of peptides. The successful candidate will be responsible for the creation, implementation and management of an integrated CMC strategy that will help validate their technology while advancing individual projects. He/she will establish and build relationships with external CMC thought leaders and consultants. The candidate will be involved in methods development for small and large scale synthesis of lipopeptide APIs and will transfer those methods to external suppliers. In this position, the successful candidate will identify, evaluate, establish, and manage relationships with, and will be responsible for ensuring the technical capabilities and quality of products from, external contract vendors. She/he will be responsible for ensuring that GMP clinical supplies are manufactured, assayed, shipped, and stored in accordance and compliance with appropriate regulatory procedures. The candidate will be responsible for preparing specifications for drug substances and drug products for clinical use and will interface with clinical centers to ensure that compounds are stored, administered, and destroyed in accordance and compliance with appropriate regulatory procedures. As Head of CMC, the Vice President will be responsible for writing and/or reviewing CMC sections of regulatory documents and submissions. The Vice President CMC will be expected to represent the CMC function at high level internal and external meetings.

Requirements:
‐ Advanced degree in Chemistry or related sciences.
‐ Minimum 10 years in the pharmaceutical or biotech industry.
‐ Minimum 6 years demonstrated leadership experience in multiple areas of CMC function such as methods
development, synthesis, analytical, QA, formulation, and manufacturing.
‐ Practical experience in peptide development required.
‐ A thorough knowledge of the drug development process, including familiarity with appropriate guidelines,
writing regulatory submissions, and demonstrated experience dealing with contract facilities is essential.
‐ Strong interpersonal, communication, and project management skills.

Please send your cover letter and resume to ruth@pharmacruiting.com

How to Apply

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