Technical Specialist

Founded in 1925 and headquartered in Akron, Ohio. Smithers is a multinational provider of testing, consulting, information and compliance services. With laboratories and operations in North America, Europe and Asia, Smithers supports customers in the transportation, life sciences, packaging, materials, components, consumer and energy industries. Smithers delivers accurate data, on time, with high touch by integrating science, technology and business expertise, so customers can innovate with confidence.

The Medical Device Testing (MDT) division was established to offer focused support to the needs of the innovative and thriving medical device and combination drug product industries. Over the past two years, both the UK and US analytical chemistry teams have invested heavily in additional chemists and new instrumentation to increase capacity and broaden the expertise for client support with world-class capabilities.

Due to this increased investment and continued success, the Medical Device Testing division is looking to recruit an experienced scientist for the position of Technical Specialist within the Chemistry Department.

This role will be primarily reporting to the Manager of Project Management.

The purpose of this role is the following:

- To provide technical leadership for analytical testing service to external and internal customers
- Translate project needs and analytical results to develop strategies for lifetime management of E&L projects
- Act as a SME for E&L on own and within a project team to work with clients to design and deliver solutions that meet customer expectations and requirements considering: budgets, timelines and regulatory requirements
- Efficient and on-time delivery of work to agreed timescales and budgets

The main duties and responsibilities are:

- Support the project team to design extractables and leachables studies, liaising with clients, project managers and other members of the project team
- Take technical lead role in the designing of multiple staged and E&L studies
- Generate, process, authorise, review and approve analytical data
- Design and execute complex projects on your own and where needed in collaboration with other SMEs using a wide range of analytical techniques, including: LC-MS/UV, GC-MS, FTIR, ICP, UV, conductivity, pH as appropriate
- To understand and determine customer requirements and prepare work proposals, study plans and budget forecasts
- Ensure all agreed targets are met on time and to the required quality standards
- Preserve and enhance your SME status by keeping abreast of current scientific advancements relevant to the business and develop your own knowledge in the field of E&L
- Support and deliver technical presentation/papers to internal and external audience, including workshops, conferences etc
- Support analytical staff and management with laboratory operations as required
- To provide project updates to customers throughout the project as agreed
- Ensures that studies meet current regulatory requirements for method development and method validation where required
- Maintain, strengthen and expand upon your customer relationships as an SME and for Smithers as a whole
- Supporting and coaching of other members of the department and business
- Ensure all project files are efficiently managed and archived in accordance with applicable SOPs
- Assist with ensuring that the relevant quality accreditations and regulations (ISO 17025, cGxP etc) are maintained and followed through full procedural compliance

To be successful in this position you will ideally need to have the following experience:

- Practical expertise and data handling with at least one of the following techniques: GC-MS or LC-MS/UV with a minimum of 3 years experience
- Experienced in Method Development & Validation in analytical chemistry
- Experience of protocol and report writing for analytical studies within the pharmaceutical industry
- Direct work experience in CRO, medical or pharmaceutical industry
- Experience of managing projects (budget, timeline and scope) responsibilities
- Competent with Microsoft Word and Excel
- Good effective and professional verbal and written communication
- Experience of working within ISO17025 or cGxP quality systems

This is an exciting time to join the Medical Device Testing department, which has seen year on year growth allowing for greater opportunities to develop your experience and career progression.

As a global employer, we offer a generous benefits package to all our employees incorporating private healthcare, pension, 25 days annual leave plus Bank Holidays per annum as well as flexible working hours which include an early finish on Fridays.