Principal Research Scientist II, Analytical Lead, R&D

About the role

The Analytical Lead owns the analytical development strategy and deliverables for assigned biologic programs and serves as the primary analytical point of contact on the CMC development teams for these programs. Deliverables span product control strategies, CQA assessments, characterization and comparability studies, release and stability packages, and regulatory submission content. The Analytical Lead is responsible for coordinating method development, validation, transfer, and clinical supply testing across internal lab teams, Quality Control, and external contract labs.

Responsibilities

• Independently conceive and own the analytical development strategy for assigned programs - including methods, specifications, CQAs, stability study plans, extended characterization, and comparability assessments - in alignment with CMC project goals.
• Translate program analytical strategy into clear, scoped work packages for internal lab teams.
• Accountable for the timely delivery of respective analytical work packages to achieve agreed upon CMC development objectives.
• Manage and oversee third-party laboratory work to ensure quality and on-time execution.
• Interpret data trends across release, stability, and characterization assays.
• Collaborate with process development and drug product development partners to define analytical strategies for process development and formulation development studies.
• Author and review regulatory submission documents, responses to health authority queries, technical reports, lab data, and method validation protocols and reports.
• Communicate strategy, risks, and key issues to the Product Development Strategy Team, functional management, and SMEs.
• Present project updates at group, department, and project team meetings.
• Plan resource and budgetary requirements for assigned programs.
• Mentor dual-role analytical leads on project management and analytical development strategies.
• Serve as a subject matter expert within the broader Biologics ARD team for processes and procedures relevant to the Analytical Lead role.
• Compile program-level analytical information into consolidated reporting for Analytical management.

Requirements

• Minimum of 16+ years of relevant industry experience with a degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
• Comprehensive knowledge of analytical methods for release, stability, and extended characterization of protein therapeutics (HPLC, capillary electrophoresis, mass spectrometry, potency assays, ELISA, cell-based functional assays, CD, DSC, light scattering).
• Proven track record in project management of analytical development activities for biologic compounds (multi-specifics, mAbs, antibody drug conjugates and/or fusion proteins).
• Experience authoring and reviewing INDs/IMPDs, including quality and characterization sections, and authoring responses to health authority queries.
• Experience leading and reviewing change records, exception reports, and laboratory investigations in a GXP environment.
• Working knowledge of global regulatory requirements applicable to analytical development of protein therapeutics (ICH, FDA, EMA).
• Statistical knowledge and hands-on experience with design of experiments, stability trending, statistical software packages (e.g. JMP).

Qualifications

• Strong technical, communication, collaboration, and critical thinking skills.
• Adaptable and flexible in the face of evolving priorities and timelines.
• Fosters a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures and manages innovation to reality.

Skills

• Self-motivated, detail-oriented, and able to work in a fast-paced team environment.

Benefits

Compensation and Leveling will be commensurate with experience. This position requires an individual who is self-motivated, detail-oriented, and able to work in a fast-paced team environment with demonstrated problem solving skills.