Biotechnology Specialist

1 day ago


London, Greater London, United Kingdom Mantell Associates Full time
Senior Biotechnologist Job Description

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm, partnering with a full integrated biopharmaceutical company to seek a Senior Biotechnologist focused on Upstream Manufacturing (Drug Substance Manufacturing).

Job Responsibilities:
  • Adhere to cGMP and EHS practices, ensuring all activities are conducted in a compliant and safe manner.
  • Perform cGMP tasks in Grade CNC, D, and C areas, demonstrating expertise and attention to detail.
  • Cultivate mammalian cells aseptically from cell revival stage to the end of production process in Single-use bioreactors, following established protocols.
  • Prepare media and buffers according to specifications, adhering to written protocols and guidelines.
  • Proactively maintain the USP suite and equipment in a state of inspection readiness, ensuring seamless operations.
  • Act as a Subject Matter Expert (SME) for written procedures, SOPs, BMRs, and other cGMP documentation within the scope of expertise.
  • Support the execution of technical and validation protocols, ensuring successful outcomes.
  • Take ownership of deviations, leading and coordinating investigations as required, to identify root causes and implement corrective actions.
  • Contribute to Technology Transfer of processes to manufacturing scale, driving efficiency and productivity.
  • Serve as a supervisor, ensuring laboratory work is carried out in accordance with cGMP regulations.
  • Coach and mentor new starters to foster a multi-skilled and engaged USP team, promoting knowledge sharing and growth.
  • Collaborate with other departments to drive business success, contributing to commercial Pre-Approval Inspections (PAIs), regular Audits, and regulatory agency interactions.
  • Continuously identify process improvements to maintain a lean, flexible, and agile manufacturing facility, embodying operational excellence.
Requirements:
  • Bachelor's degree in a related discipline or equivalent relevant experience.
  • Demonstrated knowledge and experience in mammalian cell culture for production of monoclonal antibodies and recombinant protein therapeutic products.

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