Director, PDS&T Analytical CMC Development
Full-time
Salary Range: USD 160,500 - USD 305,000 per year
AbbVie's mission is to discover and deliver innovative medicines and solutions that address serious health issues today and tomorrow.
Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy drives the analytical CMC control strategy for late‑stage development of biologics, ensuring method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy. This cross‑functional role requires strategic thinking and a strong technical analytical background in gene therapy and tLNP technologies.
Responsibilities
- Drive overall analytical control strategy, including justifying appropriate specifications, determining critical quality attributes, assessing product shelf‑life, and risk‑based comparability strategies for the biologics pipeline.
- Establish collaborations across the organization 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 and facilitate resolution within and across functional areas.
- Act as the principal contact for all stakeholders and balance conflicting expectations between cross‑functional areas.
- Actively participate in yearly FTE planning across the analytical organization.
Qualifications
- Bachelor’s Degree or equivalent in a science related field with extensive (typically 18 years) of related work; Master’s Degree or equivalent in science, pharmacy, or related field with extensive (typically 16 years) of related work; or PhD in science or related field with typically 10 years of related work experience.
- Experience in a research and/or development environment.
- Proven ability to innovate with a history of new or improved product releases.
- Strong interpersonal skills, able to interact effectively with diverse groups within function and maintain strong working relationships with internal and external collaborators.
- Demonstrated ability to influence others across areas of scientific disciplines.
- Technical background in healthcare, laboratory diagnostics, medical devices, or pharmaceutical companies.
We offer a comprehensive benefits package, including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees. This role is eligible to participate in long‑term incentive programs.
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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