Senior Biotechnologist (USP)

Mantell Associates is partnered with a full integrated speciality biopharmaceutical company, who are seeking a Senior Biotechnologist focused on Upstream Manufacturing (Drug Substance Manufacturing).

Senior Biotechnologist - Responsibilities:

• Work in accordance with cGMP and EHS practices, conducting all activities in a compliant and safe manner. Willing to take on additional activities with little or no supervision
• Perform cGMP activities in Grade CNC, D and C areas
• Culture mammalian cells aseptically from cell revival stage in shake flask until end of production process in Single use bioreactors in accordance with the relevant protocols
• Prepare media and buffers to set specifications in accordance with written protocols
• Proactively ensure the USP suite and equipment is always maintained in a state of Inspection readiness
• Be a SME author/reviewer and/or approver for written procedures, SOPs, BMRs and other cGMP documentations in span of expertise
• Assist in execution of technical and validation protocols
• Take ownership of deviations: lead and coordinate investigations as required, to help identify root cause and appropriate corrective actions
• Contribute towards Technology Transfer of processes to manufacturing scale
• Supervise and ensure laboratory work is carried out according to cGMP
• Coach and mentor new starters to contribute to achieving a multi-skilled and engaged USP team
• Contribute as required to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interactions with regulatory agencies
• Actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her
• Continually identify process improvement to help create and maintain a lean, flexible and agile manufacturing facility
• Demonstrate operational excellence within functional area of responsibilities

Senior Biotechnologist - Responsibilities:

• Degree in related discipline or sufficient relevant experience
• Knowledge/experience of mammalian cell culture for production of monoclonal antibodies and recombinant protein therapeutic products
• Hands-on experience operating upstream processing equipment
• Experience of cell culture principles, techniques, scale up, technology transfer and process validation activities
• A minimum of 5 years in biopharmaceuticals or technical field, desired
• Proven experience of coaching and mentoring others
• Experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA
• Expertise of cGMP compliance and associated documentation

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.