MSAT Senior Scientist

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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 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.

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 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.

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 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.

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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.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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