Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
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, we’re 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 https://www.abbvie.com/abbvie-north-carolina-manufacturing.html We are now recruiting our Project Director, Aseptic Operations as part of the core start up leadership team.
Key Roles and Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- Bachelor’s 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 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.
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 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
