Manager, BioNC Operational Readiness

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 .

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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!

Johnson and Johnson is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology immunology and neuroscience. J&Js significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Learn more at are expanding our team looking for enthusiastic people to develop exciting innovative integrated Industry 4.0 technology solutions to address our complex business & technical challenges. The LM platform currently comprises of Drug Substance API and Drug Product Fill/Finish manufacturing sites with both clinical & commercial capabilities in US: Malvern PA and Puerto Rico; in Europe: Leiden NL Schaffhausen CH Cork IRL; and in Asia: Incheon South Korea. We are anticipating to grow our network and this business growth will position us to become one of the world largest biopharmaceutical companies.

With this growth we are constructing a greenfield LM Drug Substance (DS) facility in Wilson NC (referred to as BioNC) and we are seeking a highly motivated and experienced Operations Readiness manager to support Operational Readiness Team to manage all end-user interests to ensure a timely startup and handover of the new LM DS facility. The Operations Readiness manager will serve as a representative for the OPR team and the user group responsible for coordinating activities within this group.

This person must maintain the highest standards of quality compliance and accountability and act in accordance with the quality and compliance core objective. Projects must be delivered in a safe- and cGMP compliant manner striving for operational excellence and flawless execution.

Key Responsibilities:

• Acting as a Point of Contact (POC) for the functional subteams and the System User group during the project phase.

• Ensuring the timely and expert execution of detailed OPR plans for the successful startup of the new facility. This includes but is not limited to equipment readiness system readiness document readiness facility readiness and resource readiness from the design phase through to the approval of the first regulatory authorization.

• Ensuring user input to create a compliant safe and efficient working environment.

• Providing timely updates on Operational Readiness status during Core Team SLT and Sponsor review meetings as appropriate.

• Keeping stakeholders (SLT) and subteam members informed of any project activities that could impact project scope timelines and current operations.

• Being accountable for seamless user support during all relevant activities such as FAT mechanical completion walkdowns commissioning and qualification (C&Q) sampling performance qualification (PQ) water/buffer engineering runs cleaning and process validation activities.

• Ensuring operators can execute their tasks effectively.

• Ensuring that relevant documentation (SOPs/WIs/MBRs/Maintenance & Calibration) is reviewed approved and effective by agreed project milestones.

• Confirming that raw materials including single-use components are qualified.

• Verifying that all outstanding actions are closed out prior to handover at each defined phase (handover from C&Q team).

• Performing handover care custody and control of areas/utilities/equipment for the Operations Team prior to Process Validation batches.

• Checking that all production areas are GMP certified at agreed milestones before engineering runs.

• Handing over the leadership and accountability for Operations Readiness activities to the Operations team upon the completion of the first GMP run.

Qualifications

Education:

• Minimum of a Bachelors Degree focused in Chemical Mechanical and/or Bioprocess Engineering is required.

Experience and Skills:

Required:

• A minimum 10 years in Pharmaceutical Manufacturing with minimum 5 years managerial experience in a (Biotech) Operations environment

• Experience leading matrix organization

• Excellent people management skills and coaching skills

• Excellent skills on flawless project execution

• Independent self-starter good organizer/ manager

• Result and performance driven

• Natural team player easy to approach good communication skills

• A change agent with strategic focus and highly result oriented

Preferred:

• A minimum 10 years in Large Molecule Pharmaceutical Manufacturing

• A minimum 3 years of LM DS Manufacturing Start-up

• Prior experience with in Multi departmental within Johnson and Johnson

• Proven knowledge in managing matrix organization

Other:

• This position may require up to 10% domestic and international travel.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

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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