Pioneering Medicines: Principal Scientist / Associate Director, Analytical Development
Pioneering Medicines
Cambridge, United States
On-site
Phd with 8+ years industry experience
Analytical method development and qualification
Cdmo and external testing oversight
This role serves as an analytical lead for in-house programs while collaborating closely with Formulation, Drug Substance, and Quality teams
Job Summary
This role serves as an analytical lead for in-house programs while collaborating closely with Formulation, Drug Substance, and Quality 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 strong 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 Quality teams.
Skills & Requirements
Must-have
PhD with 8+ years industry experience
Analytical method development and qualification
CDMO and external testing oversight
ICH-compliant stability programs
GMP documentation authoring and review
Nice-to-have
Experience with peptides and nucleic acids
Cell-based potency assay troubleshooting
Statistical analysis using JMP and Excel
Cross-functional leadership in matrixed environment
Influence on organizational growth strategy
Key Requirements
Degree in Chemistry, Biochemistry, Biology, or Pharmaceutical Sciences
PhD with 8+ years; MS with 12+; BS with 14+ relevant industry experience
Expertise in chromatographic, electrophoretic, immunological, and binding methods
Proven experience providing technical oversight of external CRO/CDMO operations