Principal Scientist/Associate Director, Process Chemistry

Odyssey Therapeutics • Boston, MA

3d • $121,000 - $182,000

About The Position

As Principal Scientist/Associate Director, Process Chemistry, you'll have primary oversight of drug substance process development for your assigned programs. Working in close partnership with Medicinal Chemistry, you'll set the process development strategy from early route design through clinical supply and lead its execution through a network of external CDMO partners. You'll represent Process Chemistry on cross-functional program teams alongside CMC, Regulatory, Quality, and Clinical Supply, as Odyssey's pipeline advances from preclinical into clinical development.

Requirements

• Ph.D. in chemistry with 8+ years of relevant pharmaceutical experience in process chemistry; or M.S. in chemistry with 15+ years of relevant pharmaceutical experience in process chemistry
• Demonstrated track record of setting and leading phase-appropriate route design, process development, specification setting, and control strategy development for API
• Experience with statistical design of experiments (DoE) and quality by design (QbD) principles
• In-depth knowledge of ICH guidelines (e.g., Q7, Q8–Q11, M7) and their application to drug substance development
• Proven experience leading drug substance development in a virtual model across multiple external CDMOs, including CDMO selection, technical oversight, and budget management
• Strong understanding of GMP requirements for early phase drug development
• Experience delivering preclinical programs into clinical development
• Experience partnering with Medicinal Chemistry to shape route design and developability during lead optimization and candidate selection
• Experience authoring and reviewing drug substance sections of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, or other regulatory dossiers) and supporting health authority interactions
• Demonstrated leadership experience, including mentoring or managing scientists and leading cross-functional teams; able to influence without direct authority
• Strategic thinker with sound scientific judgment, able to make decisions with incomplete data and balance speed, quality, and cost
• Focused on collaboration. Building and maintaining good working relationships with internal and external stakeholders is essential. Strong communication skills, both written and oral.
• Willingness to travel to various meetings or client sites, domestically or internationally when necessary

Responsibilities

• Hold primary oversight and accountability for drug substance process development on assigned programs, serving as the Process Chemistry lead and drug substance representative on cross-functional program and CMC teams
• Set process development strategy in collaboration with Medicinal Chemistry, providing early input on route selection, scalability, cost of goods, and developability during lead optimization and candidate selection, and ensuring a smooth transition of chemistry from discovery to development
• Define phase-appropriate drug substance development plans from preclinical through clinical stages, including route selection, regulatory starting material strategy, impurity control, and specification and control strategy
• Direct the design, development, and scale-up of safe, robust, phase-appropriate synthetic processes that meet program goals for timeline, quality, and cost
• Select, manage, and hold accountable external CDMO partners; set technical direction, review and approve workplans, data, and batch records, and drive resolution of technical and supply issues
• Own drug substance objectives, timelines, milestones, and budgets for assigned programs; contribute to annual planning, resource forecasting, and contract negotiations with Finance and Legal
• Anticipate technical and supply risks and develop mitigation, backup, and contingency plans to ensure uninterrupted drug substance supply
• Partner with CMC, Analytical, Formulation, Quality, Regulatory, Legal/IP, Finance, and Clinical groups to integrate drug substance plans into overall program and CMC strategy
• Lead or oversee API solid form (salt and polymorph) screening and selection in support of pharmaceutical development
• Author and review drug substance sections of CMC regulatory filings (IND, IMPD, and later-phase submissions) and represent drug substance in health authority interactions as needed
• Communicate program status, risks, and recommendations to senior leadership and governance committees
• Mentor and develop scientists, with potential for direct reports; contribute to building Process Chemistry capabilities, best practices, and the external CDMO network
• Evaluate and champion new technologies (e.g., flow chemistry, biocatalysis, process analytical technology) where they add value to programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior