MS&T Investigator

2 weeks ago

Princeton, New Jersey, United States Medvacon Life Sciences Full time
Job Overview

Shift: Monday to Friday, 8 AM to 5 PM

Essential Qualifications: Experience in gene and cell therapy manufacturing is required.

The MS&T Specialist plays a crucial role in the manufacturing process within a GMP (Good Manufacturing Practice) environment. This position involves providing technical assistance, troubleshooting manufacturing and equipment issues, and ensuring compliance with industry standards.

The MS&T Specialist collaborates closely with the Manufacturing and Quality teams to identify immediate corrective actions for any deviations, ascertain root causes, and implement sustainable preventive measures.

Key Responsibilities:

  • Serve as a subject matter expert in technology and processes.
  • Offer on-site technical support to manufacturing teams as needed.
  • Draft, review, and approve essential documentation, including batch records and standard operating procedures (SOPs).
  • Develop and approve protocols and reports in line with regulatory expectations.
  • Analyze manufacturing data to support impact assessments and investigations.
  • Manage change controls related to process and procedural modifications.
  • Lead investigations within the CAPA (Corrective and Preventive Action) system.
  • Facilitate technology transfer for new processes and product launches.
  • Conduct facility fitness assessments, gap analyses, and risk evaluations for new programs.
  • Utilize continuous improvement methodologies to address procedural and compliance gaps.
  • Identify and implement opportunities for process enhancements and operational efficiencies.
  • Represent the MSAT function and collaborate with other departments such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
  • Support validation activities for equipment and systems, including reviewing qualification documents and drafting user requirement specifications.
  • Perform gowning procedures and access the manufacturing facility.
  • Willingness to travel as required.

Educational Background:

  • Bachelor's degree or higher in a scientific discipline or Chemical/Biological Engineering.
  • A minimum of 5 years of experience in the industry.
  • At least 3 years of relevant experience in GMP biologics or cell therapy manufacturing technical support.
  • Advanced degrees are preferred.

Skills and Knowledge:

  • Strong scientific understanding of bioprocessing principles, with a preference for familiarity with cell therapy processes and cGMP.
  • Experience in process qualification and validation.
  • Experience with the establishment, validation, and licensing of new biopharmaceutical manufacturing facilities is advantageous.
  • Familiarity with program management tools is a plus.
  • Experience in collaborating with external parties and cross-functional teams.
  • Ability to communicate effectively with clients.
  • Strong verbal and written communication skills, with the ability to influence stakeholders at all levels.
  • Strategic thinking capabilities with the ability to translate strategies into actionable tasks.
  • Proficient in prioritizing tasks in a dynamic work environment.

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