- Remote, United States
- Remote
- Full-time
- $300K–$320K per year
- 10+ years
- Visa sponsorship
Lead CMC and manufacturing strategy for genetic medicines, guiding cross-functional teams and external partners to bring products from preclinical to clinical stages.
Compensation
Annual Salary: $300,000—$320,000 USD
Responsibilities
- Guide CMC and manufacturing strategy for genetic medicines, from early development through clinical supply
- Serve as a CMC expert to external partners, reviewing process, analytical, and supply plans and resolving technical issues together
- Provide technical oversight of externally conducted process development, formulation, analytical development, fill-finish, stability, and release testing, with phase-appropriate specifications and control strategies
- Collaborate with scientists across disciplines to turn early research into robust, GMP-ready processes
- Oversee quality for externally manufactured material, including audits, quality agreements, and batch disposition
Requirements
- Bachelor’s degree or an equivalent combination of education, training, and/or experience
- Nice to have: 10+ years in biotechnology or pharmaceutical industry
- Nice to have: advanced degree in chemical engineering, biochemistry, pharmaceutical sciences, molecular biology
- Nice to have: rare disease or small-population programs
- Nice to have: platform-based manufacturing