Pharmaceutical NPD Technologist - Cambridgeshire

55000.00 - 75000.00 GBP Annual + GBP55000 - GBP75000/annum
07 Feb 2017
07 Mar 2017
Contract Type
Full Time
Jason Johal is currently recruiting for a Pharmaceutical New Product Development Technologist to join the Pharmaceutical Technology Department of a dynamic and ambitious organisation that has committed itself entirely to the research and development of innovative medications across an international stage. Based at their facility in Cambridge this role is offered on a full time permanent basis and with a wide salary bracket of GBP55,000 - GBP75,000.

As a Technologist you will be responsible for the commercialisation of new products/processes, optimisation and lifecycle management of existing commercial products/processes, and ensuring the validation programs for both are in conformance with all applicable guidelines, policies, procedures and requirements.

Other responsibilities will include providing technical expertise and validation guidance to the operations teams both internal and external network locations and ensuring 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.

The specific duties and responsibilities of this role will be to:
• Take responsibility for coordinating the development, transfer and scale-up for new products and processes at Production Facilities.
• Take responsibility for 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
• Take primary responsibility to coordinate the scale-up batches of new products and processes. This includes such tasks as batch record preparation, scheduling, raw material acquisition, supervising batch manufacture, etc
• 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, optimisation, etc.
• Develop and follow validation master plans to ensure conformance with cGMP and all applicable regulatory requirements
• Identify potential product/process improvements of existing commercial dosage forms
• Take responsibility for new equipment evaluation by interfacing with engineering and equipment manufacturers to ensure proper installation and operation of the new equipment
• Liaise with technical employees and directly support technical troubleshooting of production issues relating to pharmaceutical manufacturing processes
• Evaluate and qualify alternate sources of raw materials
• Prepare validation reports, including data analysis, conclusions and recommendations

You are required to have the following qualifications, skills and experience:
• A 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 (or equivalent)
• A good 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
• A functional understanding of the operation of production equipment involved in the manufacturing process
• The ability to think on your feet and make quick/effective decisions
• Strong Problem solving skills
• The ability to effectively interact and communicate with a range of stakeholders and departments
• Effective time management and the ability to efficiently utilize available resources
• The ability to influence

The achievements of this role will have a positive impact upon the financial resources of the company. Successful scale-up of new products, or reformulation /process improvements of existing products and subsequent EMA, FDA, additional regulatory approval are part of the Pharmaceutical Technology Department goals. Errors or omissions that are not corrected during scale-up can delay approval of the product and/or result in manufacturing processes that are problematic. Successful performance of this position will help assure that the proper equipment is purchased, installed and properly operated, that processes and formulations are optimised (as needed), to sustain operational excellence for the company.

CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria. Entitlement to work in the EEA is essential. Please quote reference ST38202 in all correspondence