GMP Manufacturing Scientist

Job description:

• Perform all manufacturing operations including but not limited to component transfer and preparation, equipment and area preparation, media preparation, up and downstream manufacturing.
• Support the monitoring and maintenance of the facility and direct utilities in accordance with company & regulatory guidelines
• Execute operational activities with adherence to cGMP, SOPs, and manufacturing documentation.
• Maintain lab to production standard and maintain cell lines for use in production
• Record all activities and deviations within the QMS and participate in investigations of deviations and CAPA tasks.
• Work and write up report on analytical techniques including ELISA, SDS PAGE and Western Blot.
• Maintaining accurate records and contribute to authorship of analytical aspects of regulatory submissions, technical procedures, protocols and reports.
• Involvement in decisions on scheduling of development, technical transfer and validation in conjunction with other technical staff.
• Contribute to process improvement projects.
• Draft, review and update SOP’s and batch records.
• Maintain safe manufacturing in lab, draft COSHH’s and risk assessments for lab process.
• Provide training and supervise staff in routine activities, methods and interpretation.
• Work collaboratively with a wide range of internal and external stakeholders, including a diverse range of clients.