Principal Research Scientist I, Analytical Lead (R&D)

Allergan; South San Francisco (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

AbbVie Biologics ARD in South San Francisco seeks an Analytical Lead to own analytical development strategy for biologic programs. You will coordinate method development, validation, and testing across internal labs and CROs, while preparing regulatory submission content and reports.

This on-site role requires collaboration with cross-functional teams, strong project management, and deep experience with protein therapeutics, including antibodies and ADCs.

Qualifications

• PhD/MS/BS with extensive industry experience in analytical development for biologics.
• Experience with analytical methods for release, stability, and characterization of protein therapeutics.
• Ability to author INDs/IMPDs and respond to health authority queries.

Responsibilities

• Own analytical development strategy for assigned biologic programs.
• Coordinate method development, validation, transfer, and testing across internal and external labs.
• Prepare and review regulatory submission content and technical reports.
• Communicate strategy, risks, and issues to teams and management.
• Plan resources and budgets for programs.

Skills

HPLC

Mass spectrometry

ELISA

Capillary electrophoresis

CD

DSC

Light scattering

Statistical design of experiments

Regulatory submissions

JMP

Education

PhD with 6+ years

MS with 12+ years

BS with 14+ years

Tools

JMP

Job description

Company Description

About AbbVie

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. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

About the Team

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.

Role Summary

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.

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.

Qualifications

• 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.
• 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 flexiblein the face of evolvingprioritiesand timelines.
• Fosters a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures and manages innovation to reality.Work Environment
• This 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 Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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https://www.abbvie.com/join-us/reasonable-accommodations.html