Manager, BioNC Operational Readiness

Johnson & Johnson•Wilson, NC

4d•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! 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&J’s 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 https://www.jnj.com/innovative-medicine We 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.

Requirements

A minimum of a Bachelor's Degree focused in Chemical, Mechanical and/or Bioprocess Engineering is 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

Nice To Haves

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

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.