SVP/VP, CMC

SVP/VP, CMC Location Greater New York City Area, United States of America Job Type Full-time Description SVP/VP, CMC | Report to CEO: Pre-IPO Biotech, Proven Leadership Team | RETAINED SEARCH 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 Thomas J. Fascia Email: tfascia@cornerstonesg.com Phone: 973-656-0220x717 LinkedIn: https://www.linkedin.com/in/thomasfascia Cornerstone Search Group, LLC 1200 Morris Turnpike | Short Hills, New Jersey 07078, USA www.cornerstonesg.com Cornerstone's Privacy Policy Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not be shared with any parties outside of Cornerstone Search Group without your prior permission. Back To Featured Searches List Manage Consent To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions. 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Functional Functional Always active The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network. Preferences Preferences The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user. Statistics Statistics The technical storage or access that is used exclusively for statistical purposes. The technical stora