Pioneering Medicines: Principal Scientist / Associate Director, Analytical Development

Flagship Pioneering•Cambridge, MA

About The Position

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. 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.

Requirements

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.
Proven experience providing technical oversight of external CRO/CDMO analytical operations, including ICH-compliant stability programs and GMP testing activities.
Strong working knowledge of CMC regulatory expectations and analytical content required for global regulatory submissions.
Familiarity with statistical and data analysis tools such as JMP and Excel.
Strong technical problem-solving, risk assessment, and scientific judgment.
Excellent organizational and management skills with the ability to manage multiple priorities.
Proven ability to author, review, and approve scientific and GMP documentation.
Strong communication, collaboration, and influencing skills.

Nice To Haves

Experience with other modalities including peptides and nucleic acids is desirable.
Experience developing, qualifying, and troubleshooting cell-based potency assays is highly desirable.

Responsibilities

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.
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.
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.
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.
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.