Senior Process Chemistry Lead, Drug Substance

Odyssey Therapeutics, Inc.; Boston (MA); Sur place; USD 180 000 - 250 000; Plein temps

Résumé du poste

Odyssey Therapeutics, Inc. is seeking a Principal Scientist/Associate Director, Process Chemistry to oversee drug substance process development across programs, from early route design through clinical supply, partnering with Medicinal Chemistry and external CDMOs.

You will lead strategy, scale-up robust syntheses, manage budgets and timelines, author regulatory sections, mentor scientists, and drive innovations in flow chemistry and related technologies.

Qualifications

• Ph.D. in chemistry with 8+ years of pharma process chemistry experience, or MS with 15+ years.
• Track record leading phase-appropriate route design and process development for API.
• Experience with DoE and QbD principles.
• In-depth knowledge of ICH guidelines (Q7, Q8–Q11, M7) and their application.
• Experience leading drug substance development with multiple external CDMOs and budget management.
• Strong GMP understanding for early-phase drug development.
• Experience delivering preclinical programs into clinical development.
• Experience authoring regulatory sections and supporting health authority interactions.
• Leadership experience mentoring or managing scientists; influencing without authority.
• Strong collaboration and communication skills; travel willingness.

Responsabilités

• Oversight of drug substance process development on assigned programs.
• Set development strategy with Medicinal Chemistry; route selection and cost of goods.
• Define phase-appropriate development plans from preclinical through clinical.
• Design and scale-up of robust synthetic processes.
• Manage external CDMO partners; set direction and review data.
• Own timelines, milestones, budgets; participate in planning and negotiations.
• Anticipate risks and develop mitigations for uninterrupted supply.
• Collaborate with CMC, Analytical, Regulatory, and others to integrate plans.
• Lead API solid form screening and selection.
• Prepare and review drug substance sections of regulatory filings.
• Communicate status to senior leadership.
• Mentor scientists; build capabilities and external network.
• Evaluate new technologies like flow chemistry and biocatalysis.

Connaissances

Process chemistry lead

CDMO management

DoE & QbD

GMP knowledge

Regulatory filings

Cross-functional leadership

Strategic thinking

Communication

Mentoring

Budget management

Formation

PhD in chemistry

MS in chemistry with 15+ years

Description du poste

Odyssey Therapeutics, Inc. is seeking a Principal Scientist/Associate Director, Process Chemistry to oversee drug substance process development across programs, from early route design through clinical supply, partnering with Medicinal Chemistry and external CDMOs.

You will lead strategy, scale-up robust syntheses, manage budgets and timelines, author regulatory sections, mentor scientists, and drive innovations in flow chemistry and related technologies.