About the Role
Directs the route selection, design, and scale-up of pharmaceutical ingredient (API) processes (including instruments and equipment) from laboratory through pilot and manufacturing scale. Manages the science and engineering behind processing technologies/products to achieve cost effectiveness and improved product quality. Independently conducts synthesis and process development for preclinical/clinical candidates, including lab experimentation for compound preparation. Plans and implements development of new process formulas, establishes operating equipment specifications, and may advise manufacturing techniques/equipment changes. Liaises with Research and/or Commercial to ensure processes/designs meet customer needs. Selects, develops, and evaluates personnel to ensure efficient department operations. Solves significant-scope challenges requiring executive review/discussion.
Your Contributions
- Drives strategic vision/direction for API Development
- Directs process/instrument/equipment design and scale-up (lab to pilot to manufacturing)
- Manages development/implementation/maintenance of process methods and equipment for cost-effective, high-quality production
- Develops new process formulas; establishes equipment specifications; improves manufacturing and new equipment production
- Acts as liaison with R&D; selects/develops/evaluates staff
- Supports off-site synthesis and interaction with scale-up/manufacturing contractors
- Documents work and conducts it safely per company/department guidelines
Requirements
- BS/BA in Chemistry (or similar) + 16+ years pharmaceutical/process development and leadership OR
- Masterβs + 14+ years OR PhD + 12+ years
- Thorough understanding of organic and process chemistry/current literature
- Manufacturing expertise in Chemical Development
- Strong knowledge of cGMP requirements for API manufacturing
- Track record managing multiple programs/resources/staff
- Extensive CRO/CMO expertise (lead and team member)
- Trusted advisor; provides company-wide strategic direction
- Self-motivated, detail-oriented, decisive; can learn quickly and think independently
- Excellent interpersonal/communication and managerial skills; ability to influence/lead
Benefits (as stated)
- Base salary range: $244,100β$333,000; annual bonus (target 35% of base); equity long-term incentive eligibility; retirement match; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision coverage.