Biotechnology Manufacturing Specialist

il y a 3 jours


Paris, Île-de-France Mantell Associates Temps plein
Job Summary: We are seeking an experienced Biotechnology Manufacturing Specialist to join our team. This role involves working in compliance with current Good Manufacturing Practices (cGMP) and Environmental, Health, and Safety (EHS) guidelines.

About the Company: Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm partnering with a global biotechnology company. The company develops and manufactures biosimilars - biologic medicines that are highly similar to already approved reference biologic drugs. Our client's focus is on addressing unmet medical needs in therapeutic areas such as oncology, autoimmune diseases, and ophthalmology.

Responsibilities:
  Maintain the Downstream Processing suite and equipment in a state of inspection readiness at all times
  Perform cGMP activities in Grade CNC, D, and C areas
  Prepare media and buffers according to set specifications, adhering to written protocols
  Serve as a Subject Matter Expert (SME) in the creation, review, and approval of procedures, SOPs, Master Batch Records (MBRs), and other cGMP documentation within the scope of expertise
  Assist in executing technical and validation protocols
  Review and author deviations related to DSP processes, identify root causes, and implement corrective and preventive actions (CAPAs)
  Contribute to the successful technology transfer of processes to manufacturing scale
  Ensure laboratory work complies with cGMP standards
  Train, coach, mentor, and provide guidance to less experienced team members, fostering a skilled, engaged DSP team
  Support Pre-Approval Inspections (PAIs), regular audits, and other regulatory agency interactions
  Identify opportunities for process improvements and waste reduction, enhancing a lean, flexible, and efficient manufacturing facility

Requirements:
  Education: Degree in a relevant field or equivalent experience
  Experience: A minimum of 3 years in the biopharmaceutical or technical field is preferred
  Experience with mammalian cell culture for monoclonal antibody production and recombinant protein therapeutics
  Hands-on experience operating upstream processing equipment
  Knowledge of cell culture principles, techniques, scale-up, technology transfer, and process validation
  Ability to relocate to Nordics

About You: As a Biotechnology Manufacturing Specialist, you will contribute to an innovative, fast-paced manufacturing environment while maintaining high standards of quality and regulatory compliance. Estimated salary: £55,000 - £65,000 per annum.

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