MSAT Biotherapeutics Drug Product Senior Manager

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.

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