Principal Research Scientist II, Analytical Lead, R&D

AbbVie•San Francisco, CA

4h•$141,500 - $268,500•Onsite

About The Position

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical development of AbbVie's pipeline of innovative therapeutic biologic products. We are a world-class team of scientists and leaders united by a shared mission to drive the advancement of industry-leading analytical capabilities and meaningfully contribute to advancing AbbVie’s pipeline of innovative medicines. The Biologics ARD team at the AbbVie Bay Area site in South San Francisco has a long and rich history of biologics development. Located in a state-of-the-art facility housing end-to-end CMC development capabilities, the team works collaboratively to advance novel biologic therapeutics – including multi-specifics, ADCs, antibodies, and novel modalities – into first-in-human clinical development and through to clinical proof of concept. Careers in AbbVie Biologics ARD provide unique opportunities to work with cross-functional and global teams to drive exceptional science and innovative product development strategies. 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. The role operates within a cross-functional, on-site environment supporting a portfolio that includes multi-specifics, antibodies, ADCs, and novel modalities.

Requirements

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.
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.

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.