Bioprocess Specialist

2 months ago

Princeton, United States The Fountain Group Full time
The Fountain Group is currently seeking a Bioprocess Specialist for a prominent client of ours. This position is located in Princeton, NJ. Details for the position are as follows:

Job Description:

**ONSITE: Monday-Friday 8am-5pm**
  • 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.
  • Responsibilities:
    • 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 (Client, 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.
Qualifications:
  • Required:
    • BS, MS, or PhD (advanced degree preferred)
    • 5+ years pharma
    • 3+ years cell therapy biologic manufacturing process/tech support
    • Scientific understanding in bioprocessing principles
    • Experience in Process qualification, validation
    • Experience working with external parties and/or cross-functional teams
    • Experience interfacing with clients
  • Preferred:
    • Familiarity with cGMP
    • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
    • Experience with program management software and tools

Compensation: Up to $60 per hour depending on experience

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