Project Director, Aseptic Operations

We are now recruiting our Project Director, Aseptic Operations as part of the core start up leadership team. 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.

Responsibilities

Aseptic Suite Delivery and Accountability: Lead delivery of aseptic manufacturing suites across multiple modalities, partnering with Project Delivery and global engineering SMEs; Equipment Package and Team Leadership: Lead, coach, and guide package leads responsible for filling machines, isolators, lyophilizers, stopper processors, AVI, autoclaves, and washers; Manufacturing Representation and Decision-Making: Represent Manufacturing throughout the project lifecycle, providing operational requirements and timely decisions; Advanced Manufacturing Technology: Lead implementation of automation, robotics, data analysis, and digital twins within the manufacturing suites; Construction Quality and Technical Acceptance: Partner with Construction and Engineering to ensure suite quality and workmanship meet agreed standards; Commissioning, Qualification, and Start-Up Readiness: Partner with project and commissioning teams to commission and qualify equipment, facilities, and systems; Organization Building and Capability Development: Build the manufacturing organization as start-up and qualification activities accelerate; Transition to Aseptic Operations Leadership: Transition from project delivery into aseptic operations leadership, maintaining continuity of ownership and knowledge; Aseptic Practices, Contamination Control, and Quality Culture: Establish operational ownership of aseptic practices and contamination-control expectations; Operational Readiness and Manufacturing Organization: Own Manufacturing Operational Readiness from design through commissioning, qualification, start-up, and routine operations; Manufacturing Performance and Supply Reliability: Establish performance expectations for safety, quality, schedule adherence, throughput, yield, equipment reliability, and operating efficiency

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 an exceptional safety and quality performance; 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; Strategic and execution leadership; Aseptic manufacturing expertise; Cross-functional influence; Technical judgment and problem-solving; People leadership; Digital and technology fluency; Communication and transition leadership

Nice to have

Experience in roles that supported capital project delivery, C&Q, start-up and forming operational teams

Benefits

Paid time off (vacation, holidays, sick); Medical/dental/vision insurance; 401(k) for eligible employees; Eligible to participate in long-term incentive programs