Manufacturing Science and Technology Investigator

2 weeks ago

Princeton, New Jersey, United States Medvacon Life Sciences Full time
Shift: Monday to Friday, 8 AM to 5 PM

Essential Qualifications:
Experience in gene and cell therapy manufacturing is required. The role involves overseeing manufacturing operations within a GMP (Good Manufacturing Practice) environment. The MS&T Investigator provides technical assistance, including troubleshooting issues related to processes and equipment that arise during production.

Key Responsibilities:
  • Collaborate closely with Manufacturing and Quality teams to determine immediate corrective actions for any deviations, identify root causes, and implement long-term preventive measures.
  • Participate in the transfer of manufacturing processes and manage incoming changes, ensuring effective communication with relevant departments.
  • Lead process improvement initiatives at the facility.
  • Act as a subject matter expert in technology and processes.
  • Provide on-site technical support to manufacturing teams as needed.
  • Author, review, and approve various documents, including batch records and standard operating procedures (SOPs).
  • Draft and approve protocols and reports in compliance with internal and external regulatory standards.
  • 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.
  • Oversee technology transfer for new processes and product implementations.
  • Conduct facility fitness assessments, gap analyses, and risk evaluations when onboarding new programs.
  • Utilize continuous improvement methodologies to identify and rectify procedural and compliance gaps.
  • Identify and implement opportunities for enhancing process efficiency and operational effectiveness.
  • Represent the MS&T 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.
  • Ability to 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 industry experience.
  • At least 3 years of relevant experience in GMP biologics or cell therapy manufacturing technical support.
  • Advanced degrees are preferred.

Knowledge and Skills:
  • Strong understanding of bioprocessing principles, with a preference for familiarity with cell therapy processes and cGMP regulations.
  • Experience in process qualification and validation.
  • Experience with the startup, validation, and licensing of new biopharmaceutical manufacturing facilities is advantageous.
  • Familiarity with program management software and tools is a plus.
  • Experience working with external stakeholders and cross-functional teams.
  • 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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