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About the Role

The Analytical Lead owns the analytical development strategy and deliverables for assigned biologic programs, serving as the primary analytical point of contact on CMC development teams. Deliverables include product control strategies, CQA assessments, characterization and comparability studies, release and stability packages, and regulatory submission content. The role coordinates method development, validation, transfer, and clinical supply testing across internal teams, Quality Control, and external contract labs within a cross-functional, on-site environment.

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.
Compile program-level analytical information into consolidated reporting for Analytical management.

Requirements

Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
PhD with 6+ years, MS with 12+ years, or BS with 14+ 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) is highly preferred.
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 is desired.
Working knowledge of global regulatory requirements applicable to analytical development of protein therapeutics (ICH, FDA, EMA) highly preferred.
Statistical knowledge and hands-on experience with design of experiments, stability trending, statistical software packages (e.g. JMP) is a plus.
Must be self-motivated, detail-oriented, and able to work in a fast-paced team environment with demonstrated problem-solving 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.

Skills

Technical skills
Communication skills
Collaboration skills
Critical thinking skills
Problem solving skills
HPLC
Capillary electrophoresis
Mass spectrometry
Potency assays
ELISA
Cell-based functional assays
CD
DSC
Light scattering
Design of experiments
Stability trending
JMP

Location

South San Francisco, CA

Work Type

Full-time
On-site

Experience Level

PhD with 6+ years
MS with 12+ years
BS with 14+ years

Education Level

Salary/Compensations

USD 124500 - USD 236500 - yearly

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Long-term incentive programs

About the Company

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
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.

Equal Opportunity

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html