Technical Lead

Location
Cambridge
Salary
£50000 to £70000 per annum
Posted
04 Sep 2018
Closes
02 Oct 2018
Ref
J5604
Contact
William Blohm
Sector
Formulation
Contract Type
Permanent
Hours
Full Time
Technical Lead - Industrialisation

We are currently looking for a Technical Lead to join a leading company based in the Cambridgeshire area. As the Technical Lead you will be responsible for the commercialisation of new products/processes, optimization and lifecycle management of existing commercial products/processes, and insuring the validation programs for both are in conformance with all applicable guidelines, policies, procedures and requirements.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Technical Lead will be varied however the key duties and responsibilities are as follows:

Responsible for providing technical expertise and validation guidance to the operations teams both internal and external network locations.

Ensure successful new product development, transfer to production, proper training of production personnel in any new process and/or equipment, and lifecycle management of all processes through continual monitoring of key parameters.

Input to pharmaceutics on new products being developed, data collection and review to identify trends/opportunities for improvements, and development of action plans as appropriate.

Other objectives include new production equipment selection and evaluation; technical input on investigations and batch disposition and new/existing raw material evaluation.

Identifying potential product/process improvements of existing commercial dosage forms, as well as providing input to pharmaceutics during development and scale up of potential new commercial entities.

Coordinate validation activities for the manufacturing facilities, including process validation, equipment qualification and cleaning validation, to include validation of new products as well as re-validation of existing products as driven by changes to materials, process, optimization, etc.

Develop and follow validation master plans to ensure conformance with cGMP and all applicable regulatory requirements.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Technical Lead we are looking to identify the following on your profile and past history:

Degree in a biological science or engineering along with in-depth experience in the fields of Pharmaceutical Product Development, Technical Services and/or Process Development, Validation.

Understanding of the dosage form development process, along with an in-depth knowledge of process development techniques, cGMP regulations, EMA and DEA regulations, and recent trends in validation concepts.

Direct experience in the pharmaceutical plant technical support of operations is essential

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