Odyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address critical needs of patients with inflammatory diseases and cancer. We achieve unprecedented speed and efficiency by bringing together a target-centric approach, a toolbox of cutting-edge technologies, and a team of accomplished, world-class drug hunters. By reimagining the drug development process, we are creating a deep and broad drug pipeline that holds the potential to transform human health.
Position Details
Job Title: VP, CMC Small Molecule
Location: Boston, MA
Employment Type: Full-Time, Hybrid
Department: Non-Clinical
The Opportunity
VP CMC will oversee the company’s CMC function. The candidate will be responsible for phase appropriate CMC development and manufacturing strategies, due diligence, identifying and implementing necessary process improvements, oversight of activities at contract development and manufacturing organizations (CDMOs), as well as authoring/review of relevant submissions to regulatory agencies.
Key Responsibilities
- Experience in multiple CMC disciplines, specifically small molecules. Technical depth and a broad understanding of chemical process, analytical and formulation development.
- Be the functional area representative for Drug Substance and Drug Product on project teams
- Establishment and oversight of activities, including process optimization, solid-state and formulation development, API and drug product manufacturing at external laboratories and manufacturing facilities.
- Ability to scale out a team commensurate with the overall organizational growth – FTEs when needed and contractors to fill gaps
- Development and implementation of phase appropriate CMC development and manufacturing strategies from early clinical to commercial stages
- Identification of necessary process improvements, and management of development/ implementation of process improvements at external manufacturing sites.
- Oversight of proper execution of manufacturing runs at external CDMOs, ensuring supply for on-going and planned non-clinical studies and clinical trials.
- In coordination with Clinical Operations, Project Management and external CDMOs, forecasting of manufacturing needs and scheduling of manufacturing runs in accordance with program timelines and budgets.
- Interaction as process development and manufacturing leader with internal and external parties, including Program Management, Analytics, Regulatory Affairs, and Quality Assurance.
- Identification and communication of risks in the manufacturing process and their mitigation.
- Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, reports, regulatory filings, or other controlled documents, as needed. Contribute to building and maintaining phase-appropriate Quality infrastructure in support of external CMC operations
- Act as process and technical expert during regulatory interactions
- Representation of the company as overall manufacturing process expert during diligence and partner company interactions.
About You
- Doctorate in Chemistry or related discipline, with 15+ years of experience in manufacturing and CMC activities within the Biotechnology or Pharmaceutical industry, with significant experience in the field of small molecule drug development.
- Expertise overseeing the design of new syntheses and process improvements to achieve bulk and quality goals, to ensure that API processes and manufacture of Drug Substance can be successfully accomplished. Pre-formulation experience of physical chemistry characterization as well as salt and polymorph screening
- Experience with solid oral dosage form development with expertise in the interplay between formulation modality and in vivo performance. Experience with diverse oral dosage form technologies a plus.
- Proficient in the management of Contract Manufacturing Organizations, leading GMP manufacturing activities, and managing drug supply for clinical studies
- Operational experience and familiarity with the drug development process, including external regulatory requirements and cGMP. CMC project leadership experience is a plus.
- Well versed in authoring and reviewing CMC sections of regulatory dossiers, and interactions with global regulatory agencies. Ability to provide input on and set overall CMC strategy.
- Oversight and knowledge in interacting and coordinating efficiently with Clinical Development, Clinical Operations, Non-Clinical, Analytics, Regulatory Affairs, Program Management, Quality Assurance, and Commercial.
- Expertise in early development as well as late stage/commercial small molecules, preferably in direct management of multiple disciplines and platforms.
- Experience managing a diverse team.
- Excellent written and oral communication and collaboration skills across levels and functions.
- Ability to work independently and collaboratively, as required, in a fast-paced, team environment consisting of both internal and external team members.
- Strong initiative, accountability and willingness to take ownership and drive projects to completion.
- Accustomed “roll up their sleeves” and execute the tasks needed in a small company environment.
- Ability to set priorities, work independently and deliver results in a timely manner. A track record of achieving results in a virtual/outsourced model.
- Demonstrated proficiency in small molecule reformulation/formulation development is desirable.
