Vice President, Manufacturing

Summary Description

The Vice President, Manufacturing will lead the manufacturing function in developing and executing CMC strategies across the product life cycle for an oligonucleotide therapeutic, including manufacturing, process development, supply chain management, and technology transfer to ensure that processes and products are manufactured in compliance with all regulations and guidelines to support late-stage clinical studies, product licensure, and commercialization. The position carries the ultimate responsibility for assuring the availability of on-time, on-budget clinical supplies, launch inventories, and marketed products. The position reports directly to the Executive Vice President, Development & Technical Operations.

Job Description

  • Provide strategic leadership for sourcing, qualification, and oversight of the company’s 3rd party suppliers and contractors
  • Foster and maintain strong relationships with contract manufacturers for starting material production, API chemical synthesis/purification, drug product fill/finish and clinical trial material delivery services, including oversight of technology transfer to/from contract manufacturers
  • Ensure contractual arrangements for all third party suppliers and contractors are successfully negotiated, established, and maintained to protect the Company’s long-term interests
  • Manage continued development and refinement of risk management strategies and plans related to product supply, quality improvement, GXP compliance, and cost of goods
  • Assure best-quality CMC technical documentation is established internally and at third party partners, including characterization, qualification, and validation reports, manufacturing change management, and product comparability assessment, to support worldwide regulatory submissions and marketing applications
  • Provide senior technical leadership for the imetelstat program with concentration upon CMC and related pharmaceutical development activities necessary for product commercialization, including design and execution of API process validation, CMC responses to regulatory agency questions/correspondence, and participation in negotiations with the FDA to address CMC related regulatory feedback
  • Evaluate strategic opportunities in process technology and related intellectual property
  • Hiring, development and mentoring of manufacturing staff
  • Assess and align the organization to meet the goals of the long-range business plan

Qualifications

  • Ph.D. degree in Organic Chemistry, Chemical Engineering or related chemical sciences, scientific or engineering discipline
  • 15+ years experience in cGMP pharmaceutical manufacturing operations and supply chain management
  • Demonstrated track record of manufacturing success for production of oligonucleotides, peptides or other complex molecules
  • Significant prior interaction and negotiation with regulatory agencies, including experience with the preparation and management of CMC sections of US and EU regulatory filings, including PAI preparation, conduct, and follow-through
  • Experience with analytical methods such as NMR, HPLC, MS, LC-MS, and CGE
  • Strong understanding of US CFR, cGMP, ICH, and EMEA/FDA requirements and guidelines
  • Familiarity with all aspects of cGMP pharmaceutical operations and quality systems
  • Late-stage development and transition to commercial manufacturing operations experience
  • NDA/MAA preparation and product registration and commercialization experience
  • Track record managing activities to timelines, leading and developing people, working in a multi-disciplinary team environment
  • People management strengths, including the ability to motivate and mentor
  • Excellent written and verbal communication skills
  • Excellent scientific analysis and interpretation skills and the ability to creatively problem solve