MSAT Experienced Scientist

Johnson & Johnson Innovative Medicine•Wilson, NC

1d•Onsite

About The Position

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: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology 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! Johnson and Johnson is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Learn more at https://www.jnj.com/innovative-medicine We have a great opportunity for an MSAT Experienced Scientist to join our team; located in Wilson, NC! 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.

Requirements

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

Nice To Haves

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.

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.