MSAT Biotherapeutics Drug Product Senior Manager

What the role needs

• Wilson, North Carolina, United States of America Job Description:
• Process Design Inputs and Strategy Definition
• Provide technical leadership and subject-matter expertise for sterile manufacturing processes, including compounding, formulation, filling, optical inspection, device assembly, and packaging.
• Partner with Engineering to define cleanroom layouts, personnel and material lows, equipment placement, and other critical facility design requirements.
• Lead or support risk assessments, including Failure Mode and Effects Analysis (FMEA), to identify critical process parameters, risks, and appropriate control strategies.
• Participate in design reviews and find opportunities to improve process robustness, operational efficiency, and overall effectiveness.
• Collaborate with Quality Assurance, Global Engineering and Technology (GET), and Operations throughout commissioning, qualification, start-up, and operational readiness.
• Aseptic Processing and Contamination Control
• Own the development and lifecycle management of smoke-study and airflow-visualization strategies.
• Assess personnel and equipment interventions within critical zones and evaluate unidirectional airflow performance and aseptic process design.
• Support facility modifications, qualification activities, and operational readiness through airflow and contamination-control assessments.
• Lead aseptic process simulation (APS) and validation programs for sterile filling operations, including media-fill design, execution, evaluation, and lifecycle management.

From the employer

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. Job Function: R&D Product Development Job Sub Function: R&D Process Engineering Job Category: People Leader All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: 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! Join us as the MSAT Biotherapeutics Drug Product Senior Manager and help shape the design, start-up, and future operation of a new biologics drug product site spanning fill-finish, device assembly, and secondary packaging. This is an opportunity to serve as a senior technical leader, influence critical manufacturing and validation strategies, build positive relationships, and establish compliant, innovative operations that will support patients for years to come. Key Responsibilities: Process Design Inputs and Strategy Definition • Provide technical leadership and subject-matter expertise for sterile manufacturing processes, including compounding, formulation, filling, optical inspection, device assembly, and packaging. • Partner with Engineering to define cleanroom layouts, personnel and material lows, equipment placement, and other critical facility design requirements. • Lead or support risk assessments, including Failure Mode and Effects Analysis (FMEA), to identify critical process parameters, risks, and appropriate control strategies. • Participate in design reviews and find opportunities to improve process robustness, operational efficiency, and overall effectiveness. • Collaborate with Quality Assurance, Global Engineering and Technology (GET), and Operations throughout commissioning, qualification, start-up, and operational readiness. Aseptic Processing and Contamination Control • Own the development and lifecycle management of smoke-study and airflow-visualization strategies. • Assess personnel and equipment interventions within critical zones and evaluate unidirectional airflow performance and aseptic process design. • Support facility modifications, qualification activities, and operational readiness through airflow and contamination-control assessments. • Lead aseptic process simulation (APS) and validation programs for sterile filling operations, including media-fill design, execution, evaluation, and lifecycle management. • Define scientifically justified worst-case conditions and intervention strategies for APS studies. • Evaluate APS outcomes, environmental-monitoring data, and contamination-control trends to identify risks and drive continuous improvement. • Ensure the ongoing qualification of filling lines, personnel, and aseptic practices. • Establish and maintain the site Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1 and other global regulatory expectations. • Lead or support investigations and resolution of sterility-assurance events. • Serve as the site subject-matter expert during health authority inspections and regulatory audits. • Lead the cleaning-validation lifecycle, including strategy development, scientifically justified acceptance criteria, periodic review, and continued monitoring. • Support equipment changes, new product introductions, campaign manufacturing, and risk-based cleaning strategies for biologic and high-potency products, as applicable. • Provide technical leadership for sterilization programs, including vaporized hydrogen peroxide (VHP) decontamination, autoclave-cycle development, and sterile-filtration processes. • Evaluate sterilization-cycle changes, maintain the validated state, and support related investigations. Validation Strategy and Technical Leadership • Develop and execute site validation strategies for biologics drug-product manufacturing. • Provide technical leadership for Process Performance Qualification (PPQ) and Continued Process Verification (CPV) activities. • Author, review, and approve validation protocols, reports, risk assessments, and other technical documentation. • Serve as the technical owner for critical drug-product manufacturing processes. • Ensure alignment with the Validation Master Plan, quality-system requirements, and global regulatory expectations. • Prepare the facility for regulatory inspections and support initial Chemistry, Manufacturing, and Controls (CMC) filing strategies. • Lead technical and risk assessments for deviations, corrective and preventive actions (CAPAs), and change controls. • Drive inspection readiness and support the development of timely, technically sound regulatory responses. • Ensure compliance with current Good Manufacturing Practices (cGMP), data-integrity principles, and quality-system requirements. Leadership and Talent Development • Lead, develop, and inspire a team of validation engineers and technical professionals. • Coach and mentor team members in aseptic processing, validation, contamination control, and technical problem-solving. • Build sustainable interpersonal capability in sterile manufacturing and sterility assurance. • Foster a culture of safety, quality, accountability, inclusion, teamwork, and continuous improvement. Qualifications Education • A bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, Microbiology, or a related scientific discipline is required. An advanced degree, such as an MS, PhD, or MBA, is preferred. Experience and Skills Required • A minimum of 10 years of experience in the pharmaceutical or biotechnology industry. • A minimum of three years of leadership or people-management experience. • Proven experience in sterile biologics or large-molecule drug-product manufacturing. • Strong technical expertise in sterile drug-product operations, aseptic processing, validation, contamination control, regulatory compliance, and technical ownership. • Sound decision-making and problem-solving capabilities, supported by excellent communication, influencing, and negotiation skills and the ability to represent MSAT effectively on cross-functional, cross-site teams in a global matrix organization. • Shown success leading complex, high-impact technical investigations and risk-based decisions involving deviations, CAPAs, change controls, process performance, and sterility-assurance events. • Experience leading GMP investigations, with strong knowledge of Quality Assurance, regulatory compliance, cGMP, and Environmental Health and Safety requirements. • Deep knowledge of global regulatory expectations for sterile pharmaceutical manufacturing, including cGMP, EU GMP Annex 1, FDA and EMA requirements, data integrity, and inspection readiness. Preferred • Experience with facility start-up, prefilled syringes and vials, device assembly, cleaning and sterilization programs, technology transfer, cleanroom design, FMEA, and work within a global matrix organization. • Experience influencing cleanroom and facility-design decisions, including personnel and material flows, equipment layouts, unidirectional airflow, environmental monitoring, and contamination-control considerations. 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 www.careers.jnj.com .] 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 parent’s consent for the background check. 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 https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Agile Decision Making, Corrective and Preventive Action (CAPA), Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Engineering, Inclusive Leadership, Leadership, Process Control, Product Costing, Program Management, Project Schedule, Quality Assurance (QA), Regulatory Compliance, Research and Development, SAP Product Lifecycle Management, Team Management, Technical Research, Technologically Savvy