Director, PDS&T Analytical CMC Development

Job Description

Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving analytical CMC control strategy for late‑stage development of biologics. The Analytical CMC Strategy team ensures late‑phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works cross‑functionally with process development, regulatory, and quality within the Abbvie network.

This role requires a strategic thinker with a strong technical analytical background in gene therapy and lLNP technologies, able to manage complex projects and communicate effectively across functions.

• 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/across functional areas.
• Act as the principal contact for all stakeholders and balance conflicting expectations between cross‑functional areas.
• Participate actively in yearly FTE planning across the analytical organization.

• Bachelor’s Degree or equivalent in a science‑related field with typically 18 years of related work experience;
  Master’s Degree or equivalent with typically 16 years;
  PhD with typically 10 years.
• Experience in research and/or development environment.
• Proven ability to innovate with a history of new or improved product releases.
• Strong interpersonal skills and ability to collaborate with diverse groups.
• Ability to influence others across scientific disciplines.
• Technical background in healthcare, laboratory diagnostics, medical devices, or pharmaceutical companies.

• 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. Individual compensation paid within this range may vary depending on factors such as location. This range may be modified in the future.
• A comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
• This job is eligible to participate in the company’s long‑term incentive programs.

Note:

No amount of pay is considered 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 employer remains in the company’s sole and absolute discretion until paid and may be modified at the company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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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