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, including late-phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy. Works cross-functionally with process development, regulatory, and quality.

Responsibilities:
- Drive analytical control strategy: justify specifications, determine critical quality attributes, assess shelf-life, and define risk-based comparability strategies.
- 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.
- Serve as principal stakeholder contact and balance cross-functional expectations.
- Participate in yearly FTE planning across the analytical organization.

Qualifications:
- Bachelor’s (or equivalent) in a science field with typically 18 years’ related experience; OR Master’s/PharmD (or equivalent) with typically 16 years; OR PhD in science (or related) with typically 10 years.
- Experience in research and/or development.
- Proven innovation with history of new or improved product releases.
- Ability to work with diverse internal/external collaborators and influence across scientific disciplines.
- Technical background in healthcare, laboratory diagnostics, medical devices, or pharmaceutical companies.

Benefits (if part of posting): paid time off, medical/dental/vision insurance, 401(k), and eligibility for long-term incentive programs.