Job DescriptionRole SummaryThe 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. The role operates within a cross-functional, on-site environment supporting a portfolio that includes multi-specifics, antibodies, ADCs, and novel modalities.
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.
Qualifications- Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field. PhD with 8+ years, MS with 14+ years, or BS with 16+ years of relevant industry experience.
- 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).
- 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.
Key Competencies- Strong technical, communication, collaboration, and critical thinking skills.
- Must be 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.
Work EnvironmentThis is a full-time, on-site role located in South San Francisco, CA. The position requires daily in-person collaboration across scientific and cross-functional teams. Candidates should expect frequent interaction with both local and global colleagues.
Compensation & Leveling Compensation and Leveling will be commensurate with experience.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
