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

BioSpace; South San Francisco (CA); On-site; USD 150,000 - 230,000; Full time

Job summary

AbbVie Biologics ARD in South San Francisco, CA is seeking an Analytical Lead to own the analytical development strategy for assigned biologic programs on a full-time, on-site basis.

You will coordinate method development, validation, transfer, and testing across internal and external labs, author IND/IMPD content, and contribute to regulatory submissions while collaborating with process development and drug product teams.

Qualifications

• PhD/MS/BS with extensive industry experience in analytical development for biologics.
• Strong knowledge of release, stability, and characterization of protein therapeutics.
• Experience authoring INDs/IMPDs and regulatory responses.
• Experience managing CROs and labs in a GXP environment.
• Familiarity with ICH/FDA/EMA regulations.
• Statistical analysis and DoE familiarity.

Responsibilities

• Own analytical development strategy for assigned programs.
• Coordinate method development, validation, transfer, and testing.
• Oversee third-party labs to ensure quality and timeliness.
• Prepare regulatory submission content and reports.
• Communicate strategy and risks to leadership.
• Present updates at meetings.
• Plan resources and budget for programs.
• Compile program-level analytical information into reports.

Skills

Analytical method development

HPLC

Mass spectrometry

Characterization assays

Design of experiments

Project management

IND/IMPD authoring

GXP regulatory knowledge

Data interpretation

Cross-functional collaboration

Education

PhD with 6+ years experience

MS with 12+ years experience

BS with 14+ years experience

Tools

JMP

Job 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.

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 AbbVies 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 Companys 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.

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