Job Title: VP Technical Operations
Job Number: 29887
As Vice President, Technical Operations you will be responsible for the creation of CMC strategy for a diverse portfolio of molecules, ensuring study drugs are developed and manufactured on-time, within budget & scope. The Vice President, TechOps – will be responsible for the global outsourcing strategy.
*Experience in small molecules and monoclonal antibodies preferred
- Establish and oversee the implementation of the overall CMC strategy for all stages of programs
- Directly manage and oversee all activities of the CMC department
- Lead and oversee the development, transfer, automation and qualification of manufacturing processes for drug products for use in GLP non-clinical and cGMP clinical development
- Validation, technology transfer and resolution of technical issues during CGMP manufacturing
- Manage relationships with CMOs and collaboration partners
- Review and approve regulatory filings, specifications, change controls and Master Batch records
- Assist with CRO selection and contract negotiations and budgeting
- Lead and oversee the management and distribution of regulated drug product supplies to internal and external partners
- Lead and oversee SOPs, IQO Protocols/Reports, BPRs and Specifications for CMC activities
- Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of CPPs and CQAs, development of drug product specifications and shelf-life estimates for drug product formulations
- Review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time
- Develop and maintain an in-depth knowledge of drug product manufacturing and development technology, and the associated regulatory requirements
- Author and review CMC regulatory submissions
- Oversee Drug Supply Chain management
- Communicate project status and concerns to management and project leadership
- Effectively work with cross-functional team leaders to achieve corporate and program goals
- Ensure overall operational budget is within the approved budget and timeline
- A Ph.D. in Chemistry related sciences, e.g., Organic Synthetic Chemistry, Medicinal Chemistry, Analytical Chemistry, Pharmaceutical Sciences or Engineering, with 10-15 years’ experience in cGMP related CMC drug development or manufacturing
- Candidates must possess experience in the preparation of CMC regulatory documentation.
- The prospective candidate must show demonstrated leadership experience in CMC, preferably in more than one related CMC area, and drug development experience with molecules of varying degrees of complexity. Requires experience in development and validation cGMP chemical manufacture and cGLP analyses.
- A strong understanding of CFR Parts 58, 210, and 211; ICH; and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications is required
- Ideal candidates will possess demonstrated project management skills, as well as strong teamwork/interpersonal skills and a demonstrated ability to influence at many levels across many disciplines, both externally and internally.