Biotechnology Specialist
1 month ago
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.
- 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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