Project Director, Aseptic Operations

New to North Carolina. Known for pursuing breakthroughs in medicine.

Ready to join our team

At AbbVie we bring together talented people and innovative science to develop medicines that help patients. Now were bringing that commitment to Durham North Carolina with a new manufacturing campus that will expand our ability to produce medicines and create opportunities in the Research Triangle.

The campus will integrate advanced manufacturing laboratory technologies and AI to support the production of immunology oncology and neuroscience medicines. The first phase will include manufacturing facilities next-generation laboratories a warehouse administrative offices and employee wellness facilities.

To learn more about this investment please visit are now recruiting our Project Director Aseptic Operations as part of the core start up leadership team.

Key Roles and Responsibilities

1. Aseptic Suite Delivery and Accountability: Lead delivery of aseptic manufacturing suites across multiple modalities partnering with Project Delivery and global engineering SMEs. Own delivery against approved scope schedule budget and design and construction quality expectations.
2. Equipment Package and Team Leadership: Lead coach and guide package leads responsible for filling machines isolators lyophilizers stopper processors AVI autoclaves and washers. Establish clear accountabilities align priorities and resolve issues across equipment packages.
3. Manufacturing Representation and Decision-Making: Represent Manufacturing throughout the project lifecycle providing operational requirements and timely decisions. Ensure design choices and equipment acceptance support safe high-quality and practical manufacturing operations.
4. Advanced Manufacturing Technology: Lead implementation of automation robotics data analysis and digital twins within the manufacturing suites. Align technology decisions with operational needs and ensure the manufacturing team is prepared to use the capabilities introduced.
5. Construction Quality and Technical Acceptance: Partner with Construction and Engineering to ensure suite quality and workmanship meet agreed standards. Provide manufacturing leadership during equipment testing and acceptance at vendor facilities and on site driving resolution of issues affecting operational readiness.
6. Commissioning Qualification and Start-Up Readiness: Partner with project and commissioning teams to commission and qualify equipment facilities and systems. Lead manufacturing procedure development and readiness activities to support the transition from project delivery into operations.
7. Organization Building and Capability Development: Build the manufacturing organization as start-up and qualification activities accelerate. Define resource needs recruit and onboard team members and establish training and development to prepare the team for operational responsibilities.
8. Transition to Aseptic Operations Leadership: Transition from project delivery into aseptic operations leadership maintaining continuity of ownership and knowledge. Establish a high-performing manufacturing organization with clear accountability and the highest standards of employee safety and product quality.
9. Aseptic Practices Contamination Control and Quality Culture: Establish operational ownership of aseptic practices and contamination-control expectations. Partner with Quality Engineering Validation and Microbiology/Environmental Monitoring to align the manufacturing operating model with the contamination control strategy
10. Operational Readiness and Manufacturing Organization: Own Manufacturing Operational Readiness from design through commissioning qualification start-up and routine operations. Build and lead the manufacturing organization defining staffing shift strategy accountabilities across production leadership frontline supervision and support functions SOPs operating procedures and manufacturing business processes. Develop capability through structured onboarding technical training qualification and leadership development.
11. Manufacturing Performance and Supply Reliability: Establish performance expectations for safety quality schedule adherence throughput yield equipment reliability and operating efficiency. Develop production strategies for the intended product mix and multi-product operating model. Partner with Supply Chain Maintenance Engineering Quality and Technical Operations to resolve constraints and improve line performance while balancing GMP compliance supply reliability capacity cost and operational flexibility.

Qualifications :

Education

• Bachelors degree in engineering pharmaceutical sciences manufacturing or a related technical discipline or an equivalent combination of relevant education and experience.

Experience

• At least 15 years of aseptic operations experience in a cGMP biopharmaceutical industry with extensive floor leadership.
• Solid track record of leading high-performance manufacturing teams with an exceptional safety and quality performance.
• Experience in roles that supported capital project delivery C&Q start-up and forming operational teams is preferred.
• Extensive progressively responsible experience in aseptic manufacturing engineering including leadership of complex manufacturing equipment or facility programs.
• Hands-on leadership experience across equipment design reviews vendor and site acceptance testing commissioning qualification and manufacturing start-up.
• Experience building and developing teams establishing manufacturing procedures and training and preparing an organization for operational readiness.
• Experience implementing advanced manufacturing technologies and translating project delivery knowledge into sustainable operational capability.

Skills

• Strategic and execution leadership: Ability to connect project delivery decisions with long-term manufacturing needs while maintaining accountability for results.
• Aseptic manufacturing expertise: Strong understanding of aseptic process equipment suite integration and operational safety and quality requirements.
• Cross-functional influence: Ability to align Manufacturing Engineering Project Delivery Construction commissioning teams and equipment vendors around timely decisions.
• Technical judgment and problem-solving: Ability to evaluate complex equipment and facility issues assess delivery and operational impacts and drive resolution.
• People leadership: Strong coaching recruitment resource planning and capability-development skills.
• Digital and technology fluency: Ability to guide implementation of automation robotics data analysis and digital twins in manufacturing.
• Communication and transition leadership: Ability to communicate priorities and decisions clearly and lead teams from project execution through start-up into routine operations.

Additional Information :

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time