Johnson & Johnson Innovative Medicine · 6 hours ago
MSAT Senior Scientist
Wilson, NC
Full-time
Onsite
Senior Level
6+ years expJohnson & Johnson is a leader in healthcare innovation, focusing on developing treatments and pioneering solutions for complex diseases. The MSAT Senior Scientist will lead reduced scale model studies and oversee large-scale studies to support commercial product introduction and technology transfer in biotherapeutics manufacturing.
Pharmaceuticals
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
Qualification
Required
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
Preferred
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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
Company data provided by crunchbase