Associate Analytical and Development Scientist
Location: Skipton
Duration: 3 Months (temp rolling)
Role is 36 hours/week as they get every 2nd Friday off.
Duties:
- Management may assign or reassign duties and responsibilities to this role at any time due to reasonable accommodation or other reasons.
- Actively contributes to planning, developing and implementation of scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development (with support from senior colleagues as required).
- Adheres to departmental and Clients requirements for EH&S.
- Adheres to Clients SOP and GMP requirements.
- Accurately and contemporaneously records experimental procedures, test results and observations, and reviews data to meet corporate, regulatory and GMP requirements.
- Contributes to the development, validation and transfer of appropriate analytical methods (e.g. HPLC-UV) and/or analytical testing to support characterisation of API and drug products.
- Measures key API and/or formulation physicochemical properties to support the development process and to identify the root cause of potential stability, manufacturing and performance issues e.g. pKa, pH, solubility, disintegration, dissolution, particle size, HPLC assay, related substances etc.
- With support as required, actively manages priorities and schedules experimental work etc to meet or exceed project milestones. Regularly communicates project progress, challenges and potential delays to Laboratory Management.
- Responsible for maintaining their training curriculum in line with departmental and company-wide SOPs and GMP regulations
- As applicable, arranges/performs Preventative Maintenance (PM) and Performance Qualification (PQ) for equipment for which they are responsible.
- With support, authors technical documents such as protocols, reports, test methods, and operating procedures.
- Contributes towards the preparation of Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission.
- With support from senior colleagues as required, engages with cross-functional and cross-site teams in the design and execution of studies e.g. technical services/manufacturing, clinical, regulatory, QA/QC etc.
- Reports project progress against technical and project objectives to Product Development Manager, CMC (CMC lead) and Pharmaceutical Development Manager (functional line management).
Key Performance Indicators
- Project and associated tasks are delivered per agreed timelines.
- Projects are executed in compliance with Regulatory and Compliance (GMP and EH&S) requirements.
- General processes such as project planning, quality processes, risk management and site strategy are included in the work.
Other Skills:
- Hands-on experience in analytical chemistry, minimally being able to independently operate HPLC.
- Any of the following: LC-MS, GC, GC-MS, FT-IR, UV-vis, Karl Fischer and/or physical characterisation of API and final dosage forms.
- Bachelor’s Degree in a relevant field e.g. Chemistry, Pharmaceutical Sciences
- Master’s Degree in a relevant field e.g. Chemistry, Pharmaceutical Sciences
- Strong verbal and written communication in English
- Working knowledge of regulatory requirements, including FDA, EMEA, VICH/ICH regulations
- Some hands on experience in analytical method development and validation