General Objective of the Role:
To develop new disc products for studies and/or Clinical trials and commercial disc products to add to the existing product range. To transfer new formulations to the associated manufacturing process. To develop and use analytical and microbiological procedures to support the development and investigation of our discs products.
Key Responsibilities & Accountabilities:
- Development of formulations for new disc products.
- Development and use of new analytical procedures for development of disc products.
- Application of the following techniques during disc developments:
- Analytical procedures e.g. HPLC.
- Microbiological techniques.
- Appropriate training will be provided for both techniques, the applicant is expected to have established expertise in at least one of these disciplines.
- Testing AST products to recognised standards (eg CLSI, EUCAST, BSAC, etc)
- Maintenance of related raw materials & consumables.
- Investigation of the operational factors affecting disc manufacture.
- Working with the manager to ensure that quality standards set for existing products are maintained.
- Planning & execution of small projects in agreement with internal customers to specification in accordance with schedules and budget.
- Producing scientific reports.
- Documentation of CAPA investigations using Microsoft Project, & contribution to the company CAPA system.
- Attending team meetings, actively contributing and reporting progress.
- Representing the team in meetings with internal customers.
- Assisting R&D managers in the establishment and implementation of R&D team or department strategies.
- Fulfilling the responsibilities of the position defined in the company Health, Safety and Environmental policies, and associated codes of practice.
- Ensuring that their own work complies with the companies ISO registration.
Contacts arising from the job:
- Internal – Mainly Marketing, Operations, Planning, Compliance, QA, & QC. Others as required.
- External – Other ThermoFisher Scientific companies, raw material & equipment suppliers, selling sites, chemical & microbiological societies, clinical customers, pharmaceutical companies.
The jobholder is expected to work using microbiological and analytical chemistry techniques. They are expected to have relevant experience in at least one of these areas and extensive training will be provided on the other. Therefore the jobholder should have at least one of the following:
- A degree or equivalent in chemistry, pharmaceutical sciences or a related topic. Experience of analytical techniques, especially HPLC.
- A degree, or equivalent, in a microbiological (or related) subject. Experience in a microbiology laboratory with the ability to demonstrate competency in microbiological techniques.
In addition the jobholder should demonstrate good analytical, organisational and communication skills.
Proficiency in Microsoft Office software packages, especially Word and Excel, is required.
Some experience in the following would be of benefit but is not essential:
- A formulations development role.
- Transfer to production experience.
- Experience as an end user of antimicrobial susceptibility testing products.
- Experience with MS Project.
The jobholder is expected to:
- Work with the assistance of a Senior Scientist and higher grade colleagues. The role is mostly practical.
- Use defined procedures, but may assist with the decision process for the methods used in a project.
- Good basic knowledge of the subject, able to interpret data and, with assistance, draw valid conclusions.
- Assist with problem solving, fixing routine methods, interpreting unexpected results. Some expectation for problem solving outside their own team (for example Practical Process Improvement – PPI).
- Research ideas with guidance from Senior Scientist & Team Leader.
- Good understanding of relevant department systems. Particularly the trials and CAPA systems.
- Proficiency in Microsoft Office software packages (Word, Excel).
- Plan their own work within the boundaries of a project with assistance from Senior Scientist & Team Leader.
- Work on several projects simultaneously and, with guidance, adapt to the changing needs of the business or department.
- Communication is mainly one to one within team.
- Actively participate in team meetings and project reviews.
- Maintain formal laboratory records and internal reports.
- Establish contacts within company, as required by the project.
- Help the manager to determine the needs of internal customers.
- Help the manager to influence internal customers with data.
- Be able to establish contacts within the company lead by the project or function.
- Some presentation to groups is required.
- Train new staff within their team or in other areas.
- Help the manager to identify training needs and to participate in training that will ensure the requirements of the job are met.
- Demonstrate the Thermo Fisher values (4I’s), Integrity, Intensity, Innovation, & Involvement.
- Be able to work effectively self directed, in small teams, & on projects involving both chemical and microbiological input.
- Handle hazardous chemicals and microorganisms in a safe manner.
- Actively promote health and safety awareness to all employees within the team.