Pioneering Medicines: Principal Scientist / Associate Director, Analytical Development

Responsibilities

• Analytical Development & Lifecycle Management
• Support analytical method development, qualification, transfer, and lifecycle management for drug substance and drug product testing.
• Ensure methods are scientifically robust, phase-appropriate, and aligned with regulatory expectations.
• Contribute to specifications and control strategies across development stages.
• QC Oversight & External Testing
• Lead and coordinate QC activities across programs to support cGMP compliance and project objectives.
• Oversee external testing for release, characterization, comparability, and stability studies.
• Serve as the technical liaison for CDMOs, CROs, and contract testing laboratories.
• Data Review & Stability Programs
• Review, interpret, trend, and summarize analytical data from release and stability studies.
• Implement and support stability programs in accordance with regulatory expectations.
• Prepare technical summaries, stability assessments, and interim/final trending reports using appropriate scientific and statistical approaches.
• Compliance, regulatory and quality support
• Author, review, and approve technical and GMP documents
• Maintain strong ALCOA based data integrity practices.
• Contribute to CMC sections for INDs and related regulatory submissions.
• Support responses to agency questions and information requests.
• Support continuous improvement of quality systems related to analytical testing and QC operations.
• Cross-Functional Leadership
• Promote alignment of analytical strategies, quality expectations, and best practices across internal and external teams.
• Demonstrate scientific judgment, initiative, accountability, and the ability to influence cross-functional leaders in a matrixed environment.
• Qualifications Required:
• A degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related discipline
• PhD with 8+; MS with 12+; BS with 14+ years of relevant industry experience
• Expertise in analytical development across diverse therapeutic modalities, including chromatographic, electrophoretic, immunological, binding, and potency-based methods.
• Demonstrated success developing, optimizing, qualifying, and implementing novel analytical methods to address complex and evolving program needs.
• Strong strategic understanding of characterization approaches for proteins, biologics, mAbs and other related modalities.
• Experience with other modalities including peptides and nucleic acids is desirable.
• Proven experience providing technical oversight of external CRO/CDMO analytical operations, including ICH-compliant stability programs and GMP testing activities.
• Experience developing, qualifying, and troubleshooting cell-based potency assays is highly desirable.
• Strong working knowledge of CMC regulatory expectations and analytical content required for global regulatory submissions.
• Additional Skills
• Familiarity with statistical and data analysis tools su

Additional Information

What if... We could harness the power of Flagship's scientific platforms and create novel treatment options that benefit more patients, sooner? About Pioneering Medicines: Pioneering Medicines, Flagship Pioneering's in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagship's innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagship's multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship's bioplatform companies. Within Flagship's Innovation Supply Chain partnerships, Pioneering Medicines works with external collaborators to apply its unique approach to partners' R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production. Position Summary We are seeking an experienced and collaborative Principal Scientist / Associate Director, Analytical Development to join our Technical Operations group. This role will support analytical development, analytical control strategy, QC oversight, and day-to-day analytical operations across multiple CMC programs. Reporting to the Director of Analytical Development, this individual will serve as an analytical lead for in-house programs and partner closely with Formulation, Drug Substance, Drug Product, Quality, Regulatory, and broader CMC teams. The role will provide technical leadership within the growing team and across a global network of CDMOs and contract testing laboratories, ensuring analytical execution, regulatory compliance, and QC deliverables throughout the product lifecycle. This position offers broad cross-functional exposure, analytical ownership and the opportunity to influence analytical strategy, regulatory content, and organizational growth within a dynamic biotechnology environment.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at flagshippioneeringinc? Share your experience