Project Director, Aseptic Operations

AbbVie•Durham, NC

2d•$160,500 - $305,000•Onsite

About The Position

AbbVie is recruiting a Project Director, Aseptic Operations for the core start-up leadership team at its new manufacturing campus in Durham, North Carolina. The campus will use advanced manufacturing, laboratory technologies, and AI to support production of immunology, oncology, and neuroscience medicines. The role leads delivery of aseptic manufacturing suites across multiple modalities, partnering with Project Delivery and global engineering subject-matter experts. The director is accountable for delivery against approved scope, schedule, budget, and design and construction quality expectations; leads equipment package teams; and represents Manufacturing in project decisions. The position also guides implementation of automation, robotics, data analysis, and digital twins, and provides manufacturing leadership through equipment testing, acceptance, commissioning, qualification, and start-up. The director owns Manufacturing Operational Readiness from design through commissioning, qualification, start-up, and routine operations. Responsibilities include building and developing the manufacturing organization, establishing staffing and shift strategy, procedures, training, and operating processes, and transitioning from project delivery into aseptic operations leadership. The role establishes performance expectations and production strategies, and works across functions to support employee safety, product quality, throughput, equipment reliability, operating efficiency, and supply reliability.

Requirements

Bachelor’s degree in engineering, pharmaceutical sciences, manufacturing, or a related technical discipline, or an equivalent combination of relevant education and 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 exceptional safety and quality performance.
Extensive, progressively responsible experience in aseptic manufacturing and engineering, including leadership of complex manufacturing equipment or facility programs.
Hands-on leadership 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.
Ability to connect project delivery decisions with long-term manufacturing needs while maintaining accountability for results.
Strong understanding of aseptic process equipment, suite integration, and operational safety and quality requirements.
Ability to align Manufacturing, Engineering, Project Delivery, Construction, commissioning teams, and equipment vendors around timely decisions.
Ability to evaluate complex equipment and facility issues, assess delivery and operational impacts, and drive resolution.
Strong coaching, recruitment, resource-planning, and capability-development skills.
Ability to guide implementation of automation, robotics, data analysis, and digital twins in manufacturing.
Ability to communicate priorities and decisions clearly and lead teams from project execution through start-up into routine operations.

Nice To Haves

Experience in roles that supported capital project delivery, commissioning and qualification (C&Q), start-up, and formation of operational teams.

Responsibilities

Lead delivery of aseptic manufacturing suites across multiple modalities, accountable for approved scope, schedule, budget, and design and construction quality expectations.
Lead, coach, and guide package leads responsible for filling machines, isolators, lyophilizers, stopper processors, AVI, autoclaves, and washers; establish accountabilities, align priorities, and resolve cross-package issues.
Represent Manufacturing throughout the project lifecycle, provide operational requirements and timely decisions, and ensure design choices and equipment acceptance support safe, high-quality, practical operations.
Lead implementation of automation, robotics, data analysis, and digital twins in manufacturing suites, aligning technology choices with operational needs and preparing the team to use new capabilities.
Partner with Construction and Engineering on suite quality and workmanship; provide manufacturing leadership during equipment testing and acceptance at vendor facilities and on site, and drive resolution of operational-readiness issues.
Partner with project and commissioning teams to commission and qualify equipment, facilities, and systems.
Lead manufacturing procedure development and readiness activities for the transition from project delivery into operations.
Build the manufacturing organization as start-up and qualification activities accelerate; define resource needs, recruit and onboard team members, and establish training and development.
Transition from project delivery into aseptic operations leadership while maintaining continuity of ownership and knowledge, and establish a high-performing organization with clear accountability and strong employee-safety and product-quality standards.
Establish operational ownership of aseptic practices and contamination-control expectations; partner with Quality, Engineering, Validation, and Microbiology/Environmental Monitoring to align the operating model with the contamination control strategy.
Own Manufacturing Operational Readiness from design through commissioning, qualification, start-up, and routine operations; define staffing, shift strategy, accountabilities, SOPs, operating procedures, and manufacturing business processes.
Develop organizational capability through structured onboarding, technical training, qualification, and leadership development.
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.