Vice President Technical Operations – Pharmaceutical
The VP, Technical Operations, reporting directly to the CEO, is accountable for building and leading Chemistry, Manufacturing and Controls that will be responsible for the strategic and technical lead for all small molecule pharmaceutical development related activities including drug substance process development and manufacturing, drug product formulation development, manufacturing and supply of clinical trial materials (CTM). In this hands-on high- visibility position, the VP, Technical Operations collaborates internally with our cross-functional teams to provide drug supply chain suitable for pre-formulation, formulation development, GLP safety assessment studies and clinical programs. Externally, the VP, Technical Operations helps manage the technical transfer of processes to contract production facilities for the manufacture of cGMP CTM for use in US/Ex-US clinical trials.
- Responsible for selecting and managing external Pharmaceuticals cGMP compliant CDMOs.
- Overall responsibility for managing all CDMOs to develop and execute plans for early phase development with transition to commercial registration/validation of DS and DP in accordance with cGMP, as applicable.
- Establish a supply chain forecast strategy for clinical drug supply in collaboration with crossfunctional stakeholders.
- Provide guidance and direction for CMC development strategy, goals, budgets and other operational activities.
- Act as the senior technical leader for the CMC function, integrating internal and external team members’ activities into the pharmaceutical development plan and communicate plans and status to the Executive Team and BOD.
- Direct efforts to implement phase appropriate analytical methods development and validations, stability protocols and resulting data to ensure CDMOs are using systems and processes in compliance with all relevant regulatory standards.
- Works closely with Regulatory Affairs to plan, author and/or direct the writing and reviewing of CMC dossiers for INDs, NDAs, IMPDs, CTAs, MAAs and other regulatory submissions e.g., annual updates.
- Represent the company as the CMC expert before U.S. and European regulatory authorities (in writing or at face-to-face meetings).
- Participate and contribute to due diligence assessment of potential product licensing or company acquisition opportunities.
- Provide leadership for CMC subteams and representation at project Core teams; participate in other subteams as required.
- Lead and assist in the development and implementation of departmental processes, standard operating procedures and policies.
- Master’s or Ph.D. advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline with 15+ years of small molecule CMC development experience in a pharmaceutical or biotechnology CMC/cGMP environment.
- Proven track record of moving drug candidates from early phase development to commercial launches.
- Experienced with regulatory CMC filings in IND, NDA, IMPD, CTAs, MAAs covering all phases of preclinical and clinical development in both the US and ex-US markets; thorough knowledge of relevant regulations and guidelines such as Food and Drug Administration (FDA) and the European Medicines Agency, and International Council for Harmonization (ICH), as applicable.
- Proven ability to work collaboratively and communicate effectively on a multi-disciplinary team. Substantial experience in managing US and International CDMOs for the manufacture of cGMP APIs and DP Substantial experience in managing US and International CDMOs for the manufacture of cGMP APIs and DP.
- Excellent written, verbal communication and strong presentation skills are essential, as is willingness to work as a team player and take on multiple projects in a dynamic science driven environment.
- Demonstrated ability to build and effectively manage a group and direct reports.
- Demonstrated abilities in the design and execution of scalable synthetic routes for synthetic targets emerging from discovery research, and experience performing these syntheses in a kilo lab environment.
- Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 and commercialization and solid understanding of all aspects of CMC drug development e.g., process validation experience is essential.