Senior Manager, Drug Product Filling & Preparation Owner

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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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 more and apply to this exciting new role!

As part of a newly formed highimpact team this role will collaborate across the J&J parenteral Drug Product (DP) network to shape and execute the sites recruitment rampup strategy and launching a worldclass 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.

Key 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

Qualifications

Education:

• A Bachelors or higher degree in Life Sciences Pharmacy or Engineering is required; a Masters or higher degree is preferred

Experience and Skills:

Required:

• 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 worklife balance

• A proactive opportunity-oriented mindset that embraces calculated risk-taking and encourages entrepreneurial thinking

Preferred:

• Lean/Six Sigma certifications

Other:

• This position will be located in Wilson North Carolina and will require full time on-site support. However the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson NC.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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