MSAT Senior Scientist

Johnson & Johnson•Wilson, NC

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 https://www.jnj.com 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 Apply today for this exciting opportunity to be part of our growing team! Manufacturing Science and Technology (MSAT) manages the process technology platform strategy to produce 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, Process Analytics Introduction, and Life Cycle Management (LCM) of our commercial production processes. In this critical role within the MSAT team, the downstream senior scientist will lead reduced scale model studies in the lab, as well as oversee large-scale studies at the manufacturing facility. 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 6 years of relevant experience or Ph.D. /M.S. with a minimum of 3 year relevant experience
Expertise in lab scale downstream process development
Proven expertise in chromatography purification, viral filtration, ultrafiltration/diafiltration for monoclonal antibody process development or clinical / commercial manufacturing.
Hands-on experience with laboratory scale chromatography purification system, with the ability to design and execute experiments or projects steps with minimum supervision.
Experience within a regulated biologics or pharmaceutical industry.
Solid understanding of process control strategy and 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

Knowledge of commercial scale equipment related to downstream production
A minimum 3 years’ experience within a regulated biologics or pharmaceutical industry.
Experience in commercial scale disc stack centrifuge, transition analysis method for chromatography column qualification, and buffer in-line conditioning.
Experience in the commercial biotherapeutics drug substance manufacturing process tech transfer.

Responsibilities

Support laboratories and production facility start up activities including the preparation of SOPs and working instructions, as well as coordinating laboratories instrument installation, commissioning and qualification.
Lead the development of reduced scale chromatography and filtration 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.
Support “process fit to plant” activities by offering valuable insights to both product life cycle management and manufacturing operations.
Collaborate with the manufacturing department to support commercial manufacturing campaigns, including on-floor support.
Provide technical support by leading / assisting manufacturing investigations as required, authoring / reviewing events, deviations and CAPAs, to help meet product release specifications and timelines.
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
Collaborate with project teams to provide input, review and approval support for regulatory submissions.
Interpret project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
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 promote collaboration with internal and external partners.