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Manufacturing Science and Technology Specialist

2 months ago

Princeton, New Jersey, United States Experis Full time
Job Description

Job Title: Manufacturing Science and Technology Specialist

Job Summary:

We are seeking a highly skilled Manufacturing Science and Technology Specialist to provide technical support and expertise in gene/cell therapy manufacturing processes. The successful candidate will work closely with the Manufacturing and Quality teams to ensure the smooth operation of our GMP environment.

Key Responsibilities:

  • Provide technical support to the Manufacturing team, including troubleshooting process and equipment-related issues.
  • Work closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identify root cause, and implement long-term preventive actions.
  • Participate in process tech transfer and incoming process changes, communicate changes to applicable departments, and lead process improvement projects at the site.
  • Identify and drive continuous improvements to the manufacturing process, functioning as a technology and process subject matter expert.
  • Provide on-the-floor and on-site technical support to manufacturing when necessary.
  • Author, review, and approve various documents, including batch records, SOPs, and protocol and reports in accordance with internal and external regulatory expectations.
  • Analyze and summarize manufacturing data to support impact assessments and investigations.
  • Own change controls for process and procedure changes, lead and execute CAPA system investigations, and lead technology transfer efforts for new processes and product implementation.
  • Perform tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs, and apply continuous improvement tools to identify and close procedural and compliance gaps.
  • Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts, representing MSAT and interfacing 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.

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.
  • 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 environment.