Director, PDS&T Analytical CMC Development
About The Position
AbbVie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy drives analytical CMC control strategy for late-stage biologics development. The team supports late-phase-to-commercial method development, optimization, validation, advanced characterization, process development, regulatory authoring, and control strategy. This director-level role provides strategic and technical leadership, particularly in gene therapy and tLNP technologies, and requires management of complex projects and effective cross-functional communication. The role collaborates with process development, regulatory, quality, and other stakeholders across the AbbVie network.
Requirements
- Bachelor’s degree or equivalent education in a science-related field and typically 18 years of related work experience; or a master’s degree or equivalent science education, PharmD, or equivalent and typically 16 years of related work experience; or a PhD in science or a related field and typically 10 years of related work experience.
- Experience in a research and/or development environment.
- A strategic thinker with a strong technical analytical background in gene therapy and tLNP technologies, able to manage complex projects and communicate effectively cross-functionally.
- Technical background in healthcare, laboratory diagnostics, medical devices, or pharmaceutical companies.
- Demonstrated ability to influence others across scientific disciplines.
- Ability to interact well with diverse groups within the function and maintain strong working relationships with internal and external collaborators.
Nice To Haves
- Proven ability to innovate, with a history of new or improved product releases.
Responsibilities
- Drive the overall analytical control strategy, including specification justification, critical quality attribute determination, product shelf-life assessment, and risk-based comparability strategies for the biologics pipeline.
- Establish organizational collaborations to ensure delivery of critical analytical BLA-enabling activities.
- Set team strategies, manage resources, and define risk-mitigation strategies.
- Communicate project strategy, key issues, and risks to relevant teams; escalate risks and facilitate resolution within and across functional areas.
- Serve as the principal contact for stakeholders and balance conflicting expectations across cross-functional areas.
- Participate actively in yearly FTE planning across the analytical organization.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
