Pioneering Medicines: Principal Scientist / Associate Director, Analytical Development
Flagshippioneeringinc
Cambridge, United States
On-site
Phd or ms in chemistry/biochemistry/pharmaceutical sciences
8+ years industry experience with phd
Analytical method development and qualification
This role serves as an analytical lead for in-house programs while collaborating closely with Formulation, Drug Substance, and Regulatory teams
Job Summary
This role serves as an analytical lead for in-house programs while collaborating closely with Formulation, Drug Substance, and Regulatory teams.
The position requires technical leadership across a global network of CDMOs to ensure analytical execution and regulatory compliance throughout the product lifecycle.
Candidates will contribute to CMC sections for INDs and support responses to agency questions while maintaining ALCOA-based data integrity practices.
Matching Summary
This role serves as an analytical lead for in-house programs while collaborating closely with Formulation, Drug Substance, and Regulatory teams.
Skills & Requirements
Must-have
PhD or MS in Chemistry/Biochemistry/Pharmaceutical Sciences
8+ years industry experience with PhD
Analytical method development and qualification
CDMO and CRO oversight experience
ICH-compliant stability program management
GMP documentation authoring and review
Nice-to-have
Experience with peptides and nucleic acids
Cell-based potency assay troubleshooting
Statistical analysis using JMP software
Cross-functional leadership in matrixed environment
Strategic understanding of biologics characterization
Key Requirements
PhD with 8+ years; MS with 12+; BS with 14+ years relevant experience
Degree in Chemistry, Biochemistry, Biology, or Pharmaceutical Sciences
Expertise in chromatographic, electrophoretic, and immunological methods
Proven oversight of external CRO/CDMO analytical operations
Strong working knowledge of CMC regulatory expectations