Lead Manufacturing Biotechnologist - Clinical Projects

Lead Manufacturing Biotechnologist - Clinical Projects

RoslinCT

Edinburgh, United Kingdom

Your new role

The Lead Manufacturing Biotechnologist – Clinical Projects role is situated within the Manufacturing team who are responsible for the delivery of various Cell and Gene Therapy cell banks and drug products predominantly in the clinical phases of drug product development.

This position involves performing direct hands-on activities associated with the manufacture of these products, ensuring all required quality and regulatory standards are met. You’ll also work within a cleanroom environment and provide line management support to a team of Manufacturing Biotechnologists.

Your new role

• Supporting ongoing projects in the Manufacturing team, including processing technical transfer and GMP translation from laboratory to cleanroom;
• Completion of quality related documentation including batch production records, change controls, incidents / deviations and risk assessments in accordance with SOPs;
• Planning and supporting the validation of new production processes and equipment. Routine qualification, calibration and maintenance of production equipment;
• Providing technical leadership of manufacturing projects/campaigns;
• Point of contact for the client providing written and verbal technical / batch progress updates and other information when required;
• Line managing a team of Manufacturing Biotechnologists including managing employee performance and development.

About you

• Direct line managerial or supervisory experience;
• Experience working within a cGMP manufacturing operation, dealing with requirements in respect of aseptic processing, contamination control, documentation and record management;
• Experience of cell culture methods and techniques;
• Working knowledge of cGMP, PICS and ISO regulations;
• Exceptional verbal and written communication skills, with the ability to explain technical concepts clearly;
• Driving continuous improvement, encouraging right first-time execution;
• Taking responsibility for continually setting high standards, by developing and improving our processes;
• Excellent organisational skills, with the ability to plan ahead, deliver results and manage several tasks.

Qualifications

• A Degree within a Life Sciences discipline.