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Johnson & Johnson, MSAT Senior Scientist - Application via WayUp

WayUp, Wilson, North Carolina, United States, 27893

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Johnson & Johnson, MSAT Senior Scientist - Application via WayUp

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Johnson & Johnson, MSAT Senior Scientist - Application via WayUp

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WayUp Johnson & Johnson, MSAT Senior Scientist - Application via WayUp

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Johnson & Johnson, MSAT Senior Scientist - Application via WayUp

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WayUp This role is with Johnson & Johnson. WayUp is partnering with Johnson & Johnson to hire top talent.

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

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

J&J 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

We have a great opportunity for an MSAT Senior 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 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.

Key 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 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. 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. Qualifications Education: A minimum Bachelors Degree in Biology, Pharmacy, Chemical Engineering, Bioprocess Engineering, or similar field required Experience and Skills: Required: B.S. with a minimum 6 years of relevant experience or Ph.D. /M.S. with a minimum of 4 year relevant experience Proven expertise in CHO cell culture (upstream) biological process development or clinical / commercial manufacturing. Hands-on experience with laboratory scale bioreactors, with the ability to plan and execute experiments or projects steps with minimum supervision. 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. Preferred: 3+ years’ experience within a regulated biologics or pharmaceutical industry. Experience in scale up stainless steel bioreactor characterization and cell culture (5,000 – 20,000 L). Experience in the commercial biotherapeutics drug substance manufacturing process tech transfer. Other: _This role may require periods of travel to support startup activities based on functional needs and project timelines. In some cases, this could involve short-term stays with vendors, sister companies, or partners. In steady state, we expect travel to be

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