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Director, Biologic Drug Substance Manufacturing
Director, Biologic Drug Substance Manufacturing-April 2024
Westport
Apr 16, 2025
ABOUT ABBVIE
AbbVie is a pharmaceutical company that discovers, develops, and markets both biopharmaceuticals and small molecule drugs.
10,000+ employees
Biotechnology, Healthcare
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About Director, Biologic Drug Substance Manufacturing

  Director, Biologic Drug Substance (BDS) Manufacturing

  At AbbVie, we strive to provide leadership and direction to the Biologic Drug Substance (BDS) Network, including strategy, performance, governance, and industry best practices related to bioburden contamination control.

  We are now accepting applications for our new Director of BDS Manufacturing position. This global role supports our Internal Manufacturing and Engineering (IME) network. In the role, you will direct the Network Bioburden Contamination Control global team and activities across six manufacturing sites and various BDS Technologies. The position is accountable for defining and implementing strategies to deliver top-tier bioburden performance across the Network. You will be responsible for Bioburden Contamination Control performance governance, metrics, and Perfect Index reporting in the position and will develop and share industry best practices with the global Network across our BDS Manufacturing sites. Being accountable for defining the Network Bioburden Contamination Control Technology Strategy and driving a Multi-Year Capital Plan to deliver it is an exciting role within the AbbVie network where you can make a real impact.

  This role can be based out of Ireland, Puerto Rico, or the US, and you will get to visit and work with our teams across these regions. We offer an excellent package and opportunities to develop your career further with AbbVie.

  If you are ready to make your next move with AbbVie, please read on to find out more and get your application started.

  Key activities and role responsibilities:

  Serve as functional lead for initiatives and strategy development related to BDS Bioburden Contamination Control in IME.

  Provide Technical and Regulatory guidance to the AbbVie BDS manufacturing network.

  Drive and foster a robust Quality Culture with transparency and innovation.

  Direct the Network Bioburden Contamination Control Global team and its activities.

  Set technology strategy in alignment with Operations objectives and ensure that a Multi-Year Capital Plan is in place to deliver it. Support leadership with financial analysis and business evaluations to provide the best solutions across the BDS IME sites.

  Develop and implement strategies to advance top-tier performance in Bioburden Contamination Control across IME sites.

  Provide global governance for the bioburden contamination control best practice program in pursuit of best-in-class manufacturing practices. Drive collaboration across IME, Quality and Science and Technology (S&T) and integrate with industry experts.

  Advance BDS manufacturing expertise across the Network and proactively mentor, advise, and share industry best practices with team members, peers and senior management.

  Establish and maintain analytical tools and reporting methods for Network Bioburden Contamination Control performance.

  Support sites in Audit Readiness, Investigations, and strategy development.

  Provide on-site assessments of Bioburden Contamination control-related technology and practices.

  Key Stakeholders:

  Sr. Vice Presidents, Regional Vice Presidents, Functional Vice Presidents, site general managers

  Education and Experience required:

  Bachelor’s Degree in Microbiology, Chemical Engineering or equivalent

  Minimum 10+ years of BDS experience. Must have depth and breadth of knowledge within all aspects of BDS manufacturing.

  Business acumen and functional leadership experience are required to drive high performance across a diverse manufacturing network.

  Must have demonstrated organizational and planning skills and excellent verbal and written communication skills.

  You have demonstrated the ability to communicate with executive management effectively.

  Ability to advise and influence stakeholders within IME on Bioburden Contamination Control.

  Possess strong technical knowledge.

  AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

  AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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