Principal Research Scientist II, Analytical Lead, R&D

About the Team

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical development of AbbVies 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 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.

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 or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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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Work :

No

Employment Type :

Full-time