The Analytical Development Specialist II will contribute to the Bioassay Team, specifically in method qualification, transfer and method investigational work. Work will include executing potency methods (cell-based, protein, enzymatic as needed) according to the test method in order to evaluate method performance for all clinical phase programs. The role will also include technical transfer of the qualified methods to both internal and external partners. The candidate should have excellent people, organizational and communication skills as the role will require that the individual be an active participant of interdepartmental teams. Primary Duties
Key Skill and Competencies
- Perform testing of samples as per established test method as part of method qualification/transfer readiness or as part of a commercial investigations.
- Documents data accurately and completely as per established company guidelines and SOPs
- Contributes to technical documents such as test methods, reports, protocols, and internal presentations
- Manage laboratory equipment upkeep and record keeping
- Contributes as part of a small team of scientists towards the optimization, qualification and technical transfer of analytical methods to be used in support of biological therapeutic product release and characterization testing in a compliance-based environment in a timely manner to meet program and company timelines
- Applies technical knowledge under minimal supervision to execute method qualification and transfer activities
- Excellent communication (oral and written) and attention to detail
- Ability to be approachable, self-motivated, adaptable and manage setbacks with a positive attitude
- Strong computer, scientific, and organizational skills
- Ability to work independently under minimal supervision and as part of a collaborative team
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Understands and applies advanced scientific principles, theories, concepts, practices and standards to process and product development.
- Experience working with plate based immunological and molecular biology methods preferred especially with one or more of following methods: cell based, ELISA, MSD, Octet protein binding assays
- Statistical knowledge a plus
- Candidate must have a degree in Biology, Biochemistry or other biologically related discipline
Furthermore, candidate must have the following experience in biotechnology, pharmaceutical, or related environment :
BS with 4+ years of industry experience, or
MS with 2-4+ years of industry experience
Experience with cell based, immunoassay, enzymatic assays preferred. Experience in cell handling and cell culture using aseptic technique experience highly recommended.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.