Senior Manager, Drug Product Device Assembly and Packaging; DAP System User

Key Responsibilities:

• Serve as the Device Assembly and Packaging (DAP) Subject Matter Expert for the design, start‑up, commissioning, qualification, and routine operation of an aseptic Drug Product manufacturing facility.
• Provide technical and operational leadership to ensure DAP processes, equipment, and systems comply with cGMP, aseptic processing requirements, and global regulatory expectations.
• Author, review, and approve User Requirement Specifications (URS) and ensure alignment with aseptic processing strategy, device assembly needs, packaging requirements, and product quality attributes.
• Review and approve engineering deliverables across project phases, including Process Flow Diagrams (PFDs), P&IDs, functional design specifications, equipment specifications, automation strategies, and process descriptions specific to DAP and aseptic operations.
• Act as a key contributor to aseptic processing design, including material and personnel flows, environmental controls, line segregation, barrier/isolator or RABS strategies, and contamination prevention measures related to DAP.
• Collaborate closely with global parenteral DP sites, engineering partners, quality, automation, MSAT, and supply chain teams to ensure harmonization, best‑practice adoption, and successful project delivery.
• Develop and implement operator training strategies, including qualification plans, technical training, aseptic behavior training, and knowledge transfer for DAP operations.
• Review the deliverables from concept refresh, basis-and detailed engineering (e.g., PFD’s, P&’s, process descriptions, functional design specifications, equipment specifications).
• Write and/or review Process Support Operational documentation (Master Batch Records, SOP’s, WI’s).
• Actively support all commissioning and qualification batches.
• Support cycle development, cleaning, and hold time studies.
• Prepare and execute review & approval of validation related qualification documents and the resourcing of execution of associated tasks (water batch, engineering batch, aseptic process simulation, validation batches).
• Identify required spare parts in accordance with the approved spare part list for the support systems and liaise with relevant parties for procurement.
• Monitor and ensure all user requirements are met.
• Lead the development, review, and approval of process support operational documentation, including Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Work Instructions (WIs), and packaging/device assembly instructions.
• Define spare parts strategies for DAP and associated support systems, ensuring availability, lifecycle management, and alignment with maintenance and reliability plans.
• Ensure timely and accurate responses to information requests, regulatory questions, and audit inquiries related to DAP and aseptic manufacturing readiness.
• Execute all responsibilities within approved project timelines and budgets, proactively identifying risks and mitigation strategies to support on‑time facility start‑up and commercialization readiness.

• Education: A Bachelor’s or higher degree in Life Sciences, Pharmacy, or Engineering is required; a Master’s or higher degree is preferred.
• Experience: Minimum of 8 years in the pharmaceutical industry with technical leadership in sterile Drug Product manufacturing environments; 3–5 years as a Subject Matter Expert in Device Assembly and Packaging (DAP) for aseptically filled parenteral products.
• Skills: Strong working knowledge of aseptic processing principles, contamination control strategies, and sterile manufacturing requirements, including barrier technologies; proven experience in maintaining cGMP compliance within aseptic DP operations; proficiency with automated, digital, and robotic DAP systems; strong analytical and problem‑solving skills; ability to lead cross‑functional teams and influence stakeholders across engineering, quality, automation, MSAT, and supply chain organizations.
• Lean/Six Sigma certifications preferred.

• Agile Manufacturing, Business Intelligence (BI), Change Management, Chemistry, Manufacturing and Control (CMC), Competitive Landscape Analysis, Consulting,…