SVP/VP, CMC
Description
Cornerstone has been Retained by a Pre-IPO Biotech with a leadership team that has an impressive and proven track record. Work alongside a knowledgeable, efficient, and close-knit executive team as they drive towards curative/first in class therapies.
The Senior Vice President/Vice President, CMC will report directly to the CEO and will have full ownership/autonomy across the CMC function to include strategy, direct reports/team management, cross-functional leadership, regulatory submissions and coordinating/leading all external communication with global health authorities and vendors.
Responsibilities
- The Senior Vice President/Vice President, CMC will be responsible for all CMC activities at the company and all outsourced manufacturing of products across the development life cycle.
- Establish and oversee the implementation of the overall CMC strategy for all drug products in development.
- Assist in developing documents and maintaining compliance consistent with GLP and cGMP standards for pre-clinical, early and late-stage clinical development (pre-IND through Phase III) and regulatory submissions.
- Lead outsourcing of manufacturing activities, contract drafting and negotiation.
- Manage the sourcing, planning and distribution of manufacturing equipment, APIs, excipients and pharmaceutical packaging.
- Develop and oversee SOPs, IQO Protocols/Reports, BPRs and Specifications for Pharmaceutical Development and Manufacturing activities.
- Author and review CMC regulatory submissions
- Manage the CMC operational budget and timelines.
- Develop and implement a commercial manufacturing strategy considering future clinical and commercial demand, financial investment, CMO relationships, inventory management and supply risk.
- Develop plans to commercialization including process validation strategy, supply strategy and commercial manufacturing agreements.
- Interface closely with Quality, Regulatory, Supply Chain & Logistics and Research in development and execution of CMC plans.
- Partner with Regulatory function to build CMC regulatory strategy, communications with global regulatory agencies and CMC plans to support regulatory filings including the NDA and MAA.
Qualifications / Requirements
- PhD degree in engineering, pharmaceutical sciences, or related field is required.
- Must be willing to be based in New Jersey. Our client will not consider a hybrid model and this role requires at least 4 days a week in the office. Relocation is not offered.
- Extensive experience in pharmaceutical process development and drug product manufacturing is required.
- Significant experience interfacing with global health authorities, IND, IMPD, NDA, MAA.
Contact
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