MSAT Biotherapeutics Drug Product Senior Manager

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 .

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 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 bachelors 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 .

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.

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.

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