Ph.D. in chemistry with 8+ years or M.S. with 15+ years of pharmaceutical process chemistry experience.
Proven track record in phase-appropriate route design and process development for APIs.
Familiarity with statistical design of experiments (DoE) and quality by design (QbD) principles.
In-depth knowledge of ICH guidelines relevant to drug substance development.
Experience managing drug substance development across multiple external CDMOs.
Strong understanding of GMP requirements for early phase drug development.
Experience in authoring regulatory filings and supporting health authority interactions.
Responsibilities
Oversee drug substance process development and serve as the Process Chemistry lead.
Collaborate with Medicinal Chemistry to set process development strategy and ensure smooth transitions.
Define drug substance development plans from preclinical to clinical stages.
Direct the design and scale-up of synthetic processes to meet program goals.
Manage external CDMO partners, setting technical direction and resolving issues.
Own timelines, milestones, and budgets for assigned programs, contributing to annual planning.
Anticipate risks and develop contingency plans to ensure uninterrupted supply.
Benefits
Opportunity to mentor and develop scientists.
Access to cutting-edge technologies in process chemistry.
Collaboration with cross-functional teams across the organization.
Potential for leadership in shaping drug substance strategies.
Engagement in health authority interactions and regulatory submissions.
Full Job Description
The opportunity:
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.
Your primary objectives will be:
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
About you:
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
