Senior Scientist Formulation and Process Development
$124k/y-$161k/y
BioSpace2 days ago
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OnsiteFull-timeSenior
Summary
Insmed is seeking a Senior Scientist, Formulation and Process Development to join their Pharmaceutical and Analytical Development team in Bridgewater, NJ. The role involves leading the design, optimization, and scale-up of oral drug products supporting clinical and commercial programs.
About the Role
As a Senior Scientist, you will be responsible for hands-on formulation development, oversight of CDMO activities, and authoring high-quality technical reports and CMC regulatory documentation. You will design and develop solid oral and liquid dosage forms, interface with external manufacturing partners, and collaborate with cross-functional teams to align formulation strategy with overall CMC plans.
About You
Required:
- MS in Pharmaceutical Sciences or related discipline with 5+ years of relevant experience, or BS in Pharmaceutical Sciences with 7+ years of relevant experience.
- Proven experience in writing technical and regulatory documents, including CMC sections of INDs/NDAs.
Preferred:
- Experience with inhalation formulations.
- Strong knowledge of FDA and EMA regulatory guidelines and ICH quality standards.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Generous paid time off policies and flexible work schedules.
- 401(k) plan with competitive company match and annual equity awards.
- Access to the Company Learning Institute for skill building and mentorship opportunities.
BioSpace
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Bridgewater, NJ