Lead Manufacturing Biotechnologist - Commercial Manufacturing

Lead Manufacturing Biotechnologist - Commercial Manufacturing

RoslinCT

Edinburgh, United Kingdom

Your new role

• An exciting opportunity for a Lead Manufacturing Biotechnologist – Commercial Manufacturing to join our team;
• You will work as part of a shift team (shifts will include evening and weekend work), providing leadership to a team of employees responsible for the manufacture of an autologous, commercially licensed, Nobel prize winning CRISPR-Cas9, gene-edited product;
• Providing line management to a team of Manufacturing Biotechnologists & Technicians by managing employee performance and development and undertaking regular 1-2-1 meetings and formal reviews with direct reports;
• Responsible for the day-to-day coordination and decision-making in respect of team, while escalating more complex matters to the Manufacturing Section Manager and/or Manufacturing Manager as required;
• Liaising with Manufacturing Training team ensuring development of relevant training pathways for direct reports;
• Serving as a Manufacturing point of contact for the client by providing written and oral technical/batch progress updates and other relevant information as required;
• Planning and undertaking the validation of new production processes and equipment;
• Completing quality related documentation including batch production records, change controls, incidents/deviations and risk assessments;
• Fostering a safety-first culture by consistently adhering to all Health and Safety policies and procedures.

About you

• Prior experience working in an aseptic sterile manufacturing environment or supporting functions;
• Experience of cell culture methods and techniques;
• Working knowledge of cGMP requirements in respect of aseptic processing, contamination control, documentation and record management;
• Working knowledge of cGMP, PICS and ISO regulations;
• Exceptional communication, organisational, time management and leadership skills;
• Flexible approach to working hours: The post will involve regular weekend and evening work.

Qualifications

• Life Science degree and relevant experience within a cGMP manufacturing operation.

Apply Now