Principal Research Scientist II, Analytical Lead, R&D

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.
• 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 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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