Lead Production Scientist

Kleboe Jardine Ltd
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
An exciting and challenging opportunity has arisen for a Lead Production Scientist within a leading Contract Development and GMP Manufacturing Organisation in the ever-evolving field of Biologics and Regenerative Medicine.

As a commercially structured operation, the company displays considerable ambition in both leading the market and in building an effective physical model to meet the demand that is envisaged. This Edinburgh-based company operates at the leading edge of therapeutic discovery providing services for companies involved in European and US clinical trials.

The position will be within the Production team responsible for delivery of Manufacturing Projects. The Lead GMP Production Scientist will be responsible for performing production activities for the company's contract manufacturing operation to support the delivery of a range of cellular therapy products on a timely basis, meeting all the required quality and regulatory standards and developing the service in line with clinical and customer needs. They will provide a technical project lead for manufacturing processes and provide the technical point of contact for client communication.

They will also support the Production Supervisor with planning and organising daily activities, training other staff and making sure the department is fully compliant with current requirements of Good Manufacturing Practice and client expectations.

Some key responsibilities are listed below:

- As a key member of the Production team, ensuring manufacturing is in line with Good Manufacturing Practice within a controlled clean room environment
- Preparation and maintenance of Batch Production Records and Standard Operating Procedures
- Complete quality related documentation including batch production records, change controls, incidents/deviations and risk assessments in accordance with GMP and standard operating procedures
- Prepare formal documentation including protocols and reports for new projects to enable them to be introduced in a suitably controlled manner
- Plan and undertake the Validation of new Production processes and equipment
- Provide technical leadership of manufacturing projects and provide the technical point of contact for the client.

Qualifications Required:

The candidate should possess a Life Sciences Degree, or a related subject, or equivalent training and experience.

Skills/Experience Required:

The ideal candidate will also have:

- Experience of working within a GMP clean room production environment