Senior Manager, Drug Product Filling & Preparation Owner

Johnson & Johnson Innovative Medicine • Wilson, NC

23h • Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Learn more and apply to this exciting new role! As part of a newly formed, high‑impact team, this role will collaborate across the J&J parenteral Drug Product (DP) network to shape and execute the site’s recruitment ramp‑up strategy and launching a world‑class aseptic manufacturing operation. This role will transition from a single contributor role into a Senior Production Manager role with responsibility for the filling/preparation operations team.

Requirements

• A Bachelor’s or higher degree in Life Sciences, Pharmacy, or Engineering is required; a Master's or higher degree is preferred
• A minimum of 8 years of experience in aseptic operations (filling and preparation such as washing, autoclaving) in the pharmaceutical industry, including people leadership, is required.
• In-depth knowledge of Good Manufacturing Practice (GMP) regulations and a proven track record of successfully implementing and maintaining cGMP compliance
• Proficiency in understanding and applying digital and robotics technologies, with a commitment to staying current with emerging tools and p
• Strong creative thinking skills and a demonstrated ability to develop innovative solutions to complex challenges
• Excellent interpersonal skills, with the ability to collaborate effectively across diverse, global teams
• Demonstrated capability to analyze complex issues and formulate effective solutions in a rapidly evolving environment
• Willingness and ability to adapt to changing job requirements and work environments
• Proven capacity to manage stress and challenges effectively while promoting a healthy work–life balance
• A proactive, opportunity-oriented mindset that embraces calculated risk-taking and encourages entrepreneurial thinking

Nice To Haves

• Lean/Six Sigma certifications

Responsibilities

• Serve as Subject Matter Expert (SME) in aseptic operations, including filling and preparation activities such as washing, autoclaving, and associated support processes, within the pharmaceutical manufacturing environment
• Participation in all safety-related reviews (HAZOP, machine safety, ergonomic safety)
• Review and approval of all User Requirement Specifications (URSs)
• Review engineering deliverables from concept refresh, basis, and detailed engineering phases (e.g., PFDs, P&IDs, process descriptions, functional design specifications, equipment specifications)
• Writing and/or review of Process Support operational documentation (Master Batch Records, SOPs, WIs)
• Preparation, execution, review, and approval of validation and qualification documentation, including resourcing and execution of associated activities (water batches, engineering batches, aseptic process simulations, validation batches)
• Identification of required spare parts in accordance with approved spare parts lists for process support systems and coordination with relevant stakeholders for procurement
• Generation and execution of assigned activities in alignment with approved budgets and project schedules
• Monitoring and ensuring all user and regulatory requirements are met throughout the project lifecycle
• Management of signed URSs and timely response to requests for information
• Development of lists of disposables and associated pricing information (as applicable)
• Ensure availability and accuracy of operational documentation for all process support equipment
• Development and implementation of operator training plans for aseptic processing and support systems

What This Job Offers

• Job Type: Full-time
• Career Level: Senior