GMP Production Scientist
I have an exciting opportunity for an Applications Engineer to join a global leader in the design and manufacture of electronic instruments within medical devices, telecommunications, optical communications, defence and scientific sectors.
Currently, the company is a combination of low volume development orders combined with an increasing number of new products entering into running manufacture following qualification in customer’s products. This Scottish business is growing rapidly and is ramping up production following a move to a larger facility last year.
The company are seeking a Application Engineer to join their commercial team and report directly to the Sales and Marketing Director. This role is focused on being the key technical interface between the customer and the product development team within the business. The role encompasses extensive technical work along with the requirement to work collaboratively with the engineering teams and the customer to assist in developing new business and support current production projects.
My client is a leading Contract Development and GMP Manufacturing Organisation in the ever-evolving field of Biologics and Regenerative Medicine. Due to the expansion of the operation, they are now looking for a GMP Production Scientist to join their team.
The position will be within the Manufacturing team and will be responsible for performing production activities for the company’s contract manufacturing operation. This means that you will be at the cutting edge of therapeutic discovery providing services for companies involved in European and US clinical trials. This is an organisation that offers employees a challenging and ultimately rewarding environment and is a fantastic place for you to grow your career.
- As a member of the Manufacturing team, performing the manufacture of Cellular Therapies and Advanced Therapy Medicinal Products (ATMPs) according to Good Manufacturing Practice within a controlled clean room environment
- Complete quality related documentation including batch production records, change controls, incidents/deviations and risk assessments in accordance with GMP and standard operating procedures
- Support with the daily Manufacturing housekeeping activities, including but not limited to cleaning, stock control and ordering materials
- Preparation and maintenance of Standard Operating Procedures
- Prepare formal documentation for new projects to enable developments to be introduced in a suitably controlled manner
- Ensure that confidentiality of all information relating to clients and patients is maintained at all times
- Communicate procedures and results with clients
- Plan and undertake the Validation of new Manufacturing processes and equipment
- The post holder should possess a Life Sciences Degree, or a related subject, or equivalent training and experience.
The ideal candidate will also have:
- Experience of working within a GMP clean room production environment
- A background in stem cells, cellular therapies or cell banking
- Experience in effectively communicating with customers
- Excellent computer skills with experience in Microsoft Word and Excel
Working either in tandem with the sales and distribution team, or directly with engineers at key customers, the role will:
- Work with business development and sales team to support and develop relationships with target customers
- Assist sales staff in assessing potential applications/customers for products to meet customer needs
- Assess market penetration and product positioning to drive competitive advantage, revenues and market share
- Join sales team on customer visits at key accounts and/or at key opportunities
- Co-ordinate and generate the technical data (compliance matrices, drawing reviews etc.) required to pursue customer opportunities.
- Lead & coordinate efforts to provide technical product collateral materials, apps notes, technical articles , etc.
- Good degree in Optic or related subject.
- Knowledge of optical design
- A solid level of professionalism, interpersonal skills, and overall communication skills
Ultimately, this is an opportunity for a driven engineer who is ready for a different challenge and to be part of a company at the cutting edge of what’s possible.