MSAT Experienced Scientist

MSAT Experienced Scientist

Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new Bio-Processing Facility in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes.

In this critical role within the MSAT team, the upstream Experienced scientist will support/lead reduced scale CHO cell culture model studies in the lab. This position will support commercial product introduction through technology transfer, assist process validation, and provide technical support for manufacturing investigations and health authority inspections.

Key Responsibilities:

• Support MSAT laboratory start up activities including the preparation of SOPs and working instructions, as well as coordinating laboratory instrument installation, commissioning and qualification.
• Support/lead the development and qualification of reduced scale cell culture model by generating protocols/reports, executing laboratory scale studies, and conducting scientific reviews of data to support commercial scale biotherapeutics drug substance cGMP manufacturing.
• Support technical transfer and validation activities through scientific review of proposed manufacturing processes, technical authoring of protocols/reports, execution of laboratory scale studies and collaboration with manufacturing operations.
• Collaborate with the manufacturing operations department to support commercial manufacturing campaigns, including on-floor support.
• Participate in cross functional teams for the incorporation of process parameters into batch records and associated automation documents to ensure right-first-time process execution
• Lead training within the group on new processes, procedures, and use of equipment in the lab.
• Foster a culture of lean principles and continuous improvement within the department while promoting collaboration with internal and external partners.

Qualifications

Education:

• A minimum Bachelors Degree in Biology, Pharmacy, Chemical Engineering, Bioprocess Engineering, or similar field required

Experience and Skills:

• B.S. with a minimum 4 years of relevant experience or M.S. with a minimum of 2 years relevant experience
• Proven expertise in CHO cell culture (upstream) biological process development, with the ability to plan and execute experiments or projects independently with minimum supervision.
• Strong hands-on laboratory mindset and expertise in laboratory scale bioreactor operation including set up and tear down of bioreactors, conduct sampling and testing.
• Experience with in a regulated biologics or pharmaceutical industry.
• Solid understanding of process control strategy and its implementation in the manufacturing environment.
• Excellent oral and written communication skills. Strong technical writing capability with keen attention to detail.
• Self-motivated with a dedication to staying up to date with regulatory and technical developments in the industry.
• Ability to work independently as well as in a cross-functional team environment, demonstrating strong collaboration skills and flexibility.
• Proven track record to adapt to rapid changes in project priorities and requirements.
• Advanced root cause problem solving with strong scientific data driven decision making ability.

Preferred:

• A minimum 2 years of experience within a regulated biologics or pharmaceutical industry.
• Experience in scaling up a cell culture process from a bench-top bioreactor to a production scale.
• Experience in the commercial biotherapeutics drug substance manufacturing process tech transfer.

Other:

• 5 days onsite location is required
• Availability to work occasional weekend shifts

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.