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. The Analytical CMC Strategy team is responsible for ensuring 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 tLNP technologies, manage complex projects, and effectively communicate cross-functionally.

Responsibilities:

• Drives 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.

• Setting team strategies, managing resources and defining risk mitigation strategies.

• Communicate project strategy, key issues, and risks to relevant teams and escalate risks and facilitate resolution within/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

• Bachelor’s Degree or equivalent education in Science related field with extensive (typically 18 years) of related work; Master’s Degree or equivalent education Science or PharmD or equivalent education with extensive (typically 16 years) of related work; PhD in Science or related field with typically 10 years of related work experience.

• Experience in research and/or development environment.

• Proven ability to innovate with a history of new or improved product releases.

• Interacts well with diverse groups within function and maintains 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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• 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 at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be 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 employee remains in the Company's sole and absolute discretion unless and 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html