- Application of chromatography and purification knowledge to drive process improvements, process redesign and scale up.
- Maintain links with appropriate chromatography suppliers to ensure up to date technology is evaluated for use by the organisation.
- Design and complete feasibility studies, experiments and protocols.
- Assess new materials and equipment where necessary and give feedback on suitability for use.
- Carry out full process and equipment validation where required
- To ensure hazardous chemicals and reagents are handled appropriately and according to COSHH regulations.
- Work to appropriate cGMP and ISO/ quality standards.
- To critically evaluate analytical methods and equipment to maintain highest possible standards.
- To develop/contribute to new techniques/scientific understanding to improve upon existing and future products.
- Be fully trained in all key skills required and participate in necessary training and development in order to achieve this.
- Identify any further training/development needs required and communicate these to their manager. To develop existing and future knowledge within TBSG and promote a culture of learning.
- Be responsible for updating and maintaining their training records as training is received and ensure that evidence of competency is stored with the training record.
- To critically evaluate analytical methods and equipment to maintain the highest possible standards.
- To understand the scientific principles of methods in order to solve problems and troubleshoot.
- To participate and advise upon ongoing research and development projects initiated in other areas.
- To stay ahead of improvements made within the company in a bid to employ them within the role
- Degree in Chemistry, Biochemistry or appropriate subject ( Biological Sciences)
- Post-graduate qualification including chromatography-based research
- Comprehensive knowledge of protein purification methods, including chromatographic methods.
- Validated Chromatography column manufacturing experience including ligand conjugation and column packing.
- Experience of column packing up to 5L volume.
- Experience in method writing using UNICORN software
- Comprehensive knowledge or experience of downstream process development including relevant analytical assays (electrophoresis, ELISA, HPLC, diafiltration/ ultrafiltration)
- Experience of process validation
- Experience of working with immunoassays, specifically Nephelometric or Turbidimetric assays.
- Previous experience of working in quality control in a regulated industry.
- Good working knowledge of Microsoft Word and Excel
- Excellent communication skills, verbal and written
- The ability to multi-task
- The ability to work as part of a team
- The ability to work to deadlines
- To be flexible to the needs of the business
- Excellent organisational and time management skills.
- A methodical approach and attention to detail
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Scientist I, Formulation - Birmingham, United Kingdom - Thermo Fisher Scientific
Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Our work in specialty diagnostics – from providing diagnostic assays and instruments to clinical monitoring across disease stages – improves the diagnosis and management of blood cancers and immune system disorders. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.
Location/Division Specific Information
The Binding Site Group, a part of Thermo Fisher Scientific, is a global leader in specialty diagnostics, provides diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders. The Binding Site's Freelite offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease by major clinical guideline publications. In addition, The Binding Site is an active and influential contributor to the broader scientific community. To find out more visit
The post holder will be responsible for the design of new processes, scale up, as well as recommending and driving process improvements to existing techniques to improve column manufacturing and chromatography efficiency.
Development projects will vary in complexity and typically involve a high percentage of hands on practical work.
The post holder will be encouraged to work with many departments throughout the company notably research, development and manufacturing.
Key Communications and Working Relationships
Internal: Chromatography team members, Improvement team within Manufacturing support, primary manufacturing department and Quality team.
PERSON SPECIFICATION
Essential:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Scientist I, Formulation professionals in Birmingham
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