Director, PDS&T Analytical CMC Development

Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving the analytical CMC control strategy for late-stage development of biologics. Ensures late phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. Works cross-functionally with process development, regulatory, and quality. Requires strategic thinking with strong technical analytical background in gene therapy and tLNP technologies, complex project management, and cross-functional communication.

Responsibilities:
- Drive overall analytical control strategy: justify specifications, determine critical quality attributes, assess product shelf-life, and develop risk-based comparability strategies for the biologics pipeline.
- Establish collaborations to deliver critical analytical BLA enabling activities.
- Set team strategies, manage resources, and define risk mitigation strategies.
- Communicate project strategy, key issues, and risks; escalate and facilitate resolution across functional areas.
- Serve as principal contact for stakeholders; balance conflicting expectations across cross-functional areas.
- Participate in yearly FTE planning across the analytical organization.

Qualifications:
- Bachelor’s in a science-related field with typically 18 years related work; or Master’s in science/PharmD/equivalent with typically 16 years; or PhD with typically 10 years.
- Experience in research and/or development environment.
- Proven ability to innovate with history of new or improved product releases.
- Ability to maintain strong internal/external collaborator relationships.
- Demonstrated ability to influence others across scientific disciplines.
- Technical background in healthcare, laboratory diagnostics, medical devices, or pharmaceutical companies.