MSAT Biotherapeutics Drug Product Senior Manager
About The Position
Johnson & Johnson is seeking a senior technical leader to help shape the design, start-up, and future operation of a new biologics drug-product site in Wilson, North Carolina. The site will span fill-finish, device assembly, and secondary packaging. The role influences manufacturing and validation strategies and establishes compliant, innovative operations to support patients. The Senior Manager provides technical leadership and subject-matter expertise for sterile manufacturing processes, including compounding, formulation, filling, optical inspection, device assembly, and packaging. The role partners with Engineering, Quality Assurance, Global Engineering and Technology, and Operations on facility design, commissioning, qualification, start-up, and operational readiness. The position leads or supports aseptic processing, contamination control, validation, cleaning-validation, and sterilization programs. It develops site strategies and technical documentation, supports regulatory inspections and initial CMC filing strategies, and helps ensure compliance with cGMP, data-integrity principles, quality-system requirements, and global regulatory expectations. The role also leads and develops a team of validation engineers and technical professionals. The position is located in Wilson, North Carolina, and requires full-time on-site support. During facility design at an engineering firm, frequent travel of more than 75% is required until the project shifts to the Wilson plant site.
Requirements
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, Microbiology, or a related scientific discipline.
- At least 10 years of experience in the pharmaceutical or biotechnology industry.
- At least 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, excellent communication, influencing, and negotiation skills, and ability to represent MSAT on cross-functional, cross-site teams in a global matrix organization.
- Demonstrated 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 and 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.
- Ability to provide full-time on-site support in Wilson, North Carolina, and undertake frequent travel exceeding 75% during the facility-design phase.
Nice To Haves
- Advanced degree such as an MS, PhD, or MBA.
- 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.
Responsibilities
- Provide technical leadership and subject-matter expertise for sterile manufacturing processes, including compounding, formulation, filling, optical inspection, device assembly, and packaging.
- Partner with Engineering on cleanroom layouts, personnel and material flows, equipment placement, and other facility design requirements.
- Lead or support risk assessments, including FMEA, to identify critical process parameters, risks, and control strategies.
- Participate in design reviews and identify opportunities to improve process robustness, operational efficiency, and effectiveness.
- Collaborate with Quality Assurance, Global Engineering and Technology, and Operations during commissioning, qualification, start-up, and operational readiness.
- Own development and lifecycle management of smoke-study and airflow-visualization strategies; assess interventions, unidirectional airflow, and aseptic process design.
- Support facility modifications, qualification activities, and operational readiness through airflow and contamination-control assessments.
- Lead aseptic process simulation and validation programs for sterile filling, including media-fill design, execution, evaluation, and lifecycle management.
- Define scientifically justified worst-case conditions and intervention strategies for aseptic process simulation studies.
- Evaluate simulation outcomes, environmental-monitoring data, and contamination-control trends to identify risks and drive improvement.
- Ensure ongoing qualification of filling lines, personnel, and aseptic practices.
- Establish and maintain the site Contamination Control Strategy in alignment with EU GMP Annex 1 and global regulatory expectations.
- Lead or support investigations and resolution of sterility-assurance events; serve as site subject-matter expert during health authority inspections and regulatory audits.
- Lead the cleaning-validation lifecycle, including strategy, 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 decontamination, autoclave-cycle development, and sterile-filtration processes.
- Evaluate sterilization-cycle changes, maintain the validated state, and support related investigations.
- Develop and execute site validation strategies for biologics drug-product manufacturing.
- Provide technical leadership for Process Performance Qualification and Continued Process Verification activities.
- Author, review, and approve validation protocols, reports, risk assessments, and other technical documentation.
- Serve as technical owner for critical drug-product manufacturing processes and 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 filing strategies.
- Lead technical and risk assessments for deviations, corrective and preventive actions, and change controls.
- Drive inspection readiness and support timely, technically sound regulatory responses.
- Ensure compliance with current Good Manufacturing Practices, data-integrity principles, and quality-system requirements.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
