Our client, one of the largest Pharma companies in the U.S., is looking for a Investigator, MS&T (Manufacturing Science and Technology) which is located at Princeton NJ. Looking for MS&T Specialist to provide technical support and expertise in gene/cell therapy manufacturing processes
Job Title: Investigator, MS&T (Manufacturing Science and Technology)
Location: Princeton NJ
Pay rate: $60 Per HR
MUST HAVE:
GENE/CELL THERAPY MANUFACTURING EXP.
The MS&T Specialist provides technical support to Princeton, NJ Facility.
Manufacturing processes in a GMP environment.
Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process.
The MS&T Specialist works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions.
Other responsibilities include participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site.
The MS&T Specialist works to identify and drive continuous improvements to the manufacturing process.
Functions as a technology and process subject matter expert.
Provides on-the-floor and on-site technical support to manufacturing when necessary.
Author, review and approve, as needed, various documents (eg. Batch records, SOPs).
Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer).
Analyze and summarize manufacturing data to support impact assessments and investigations.
Owner of change controls for process and procedure changes.
Lead and executes CAPA system investigations.
Leads technology transfer efforts for new processes and product implementation.
Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.
Applies continuous improvement tools to identify and close procedural and compliance gaps
Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts. Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirement specifications, and participating on impact assessments.
Ability to perform gowning activities and enter the manufacturing plant.
Some travel will be required.
Education or Equivalent Requirements:
BSc and/or Advanced degree in Science or Chem/Bio Engineering.
Minimum 5 years of industry experience.
Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support.
Advanced degree(s) preferred
Knowledge/Skills Requirements:
Scientific understanding in bioprocessing principles.
Familiarity with cell therapy processes and cGMP is strongly preferred.
Experience in Process qualification, validation
Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus
Experience with program management software and tools are a plus
Experience working with external parties and/or cross-functional teams
Experience interfacing with clients
Possess strong verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize tasks in a highly dynamic environmentIf this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.