Role: Senior Method Development Chemist
Location: North Yorkshire
Russell Taylor Group has a fantastic opportunity for a Senior Method Development Chemist to join a global pharmaceutical company. You will have vast experience in Method Development and Validation of HPLC / Dissolution. To be eligible for this role you must have a minimum of 5 years' experience!
- Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development.
- Independently designs, develops, optimizes and executes analytical laboratory experiments.
- Develop, validate and transfer (as applicable) analytical methods, suitable for progressive stage of pharmaceutical development.
- Measures key API and/or formulation physicochemical data 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.
- Actively manages priorities and schedules experimental work etc to meet or exceed project milestones. Regularly communicates project progress, challenges and potential delays to stakeholders.
- Responsible for maintaining their training curriculum in line with departmental and company-wide SOPs and GMP regulations.
- Troubleshoots analytical issues that may occur during product development, validations, manufacturing processes, tech transfer/scale-up.
- Development of suitable and robust analytical methods based upon quality by design (QBD) concepts
- Assist in the definition of drug substance and drug product specifications with the understanding of clinical study design and CMC process.
- Timely monitoring and evaluation of release and stability data for GMP compliance, out of specifications, out of trend, and method performance issues, conduct and co-ordinate investigations and recommend corrective and preventative actions as needed.
- Manages relationships and output of internal and/or contract labs that may be carrying out development activities on company's behalf.
- Provides technical guidance in analytical activities to less experienced colleagues.
- As applicable, arranges/performs Preventative Maintenance (PM) and Performance Qualification (PQ) for equipment for which they are responsible.
- Assists in the preparation of Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission.
- Independently authors and reviews technical documents, such as protocols, technical reports, test methods, and operating procedures.
- Accurately and contemporaneously records experimental procedures, test results and observations, and reviews data to meet corporate, regulatory and GMP requirements.
- Actively managing working relationships through engagement with cross-functional and cross-site teams in the design and execution of studies e.g. technical services/manufacturing, clinical, regulatory, QA/QC etc.
- Adheres to departmental requirements for EH&S.
- Adheres to SOPs and GMP requirements.
- Reports project progress against technical and project objectives to Product Development Manager, CMC (CMC lead) and Pharmaceutical Development Manager (functional line management).
- 5 years + experience in development of various dosage forms; HPLC, LC-MS, GC, GC-MS, FT-IR, UV-VIS, Karl Fischer and experience in API / final dosage form.
- Have a Bachelors, Masters or PhD in Chemistry, Pharmaceutical or relevant field.
- Years experience in Analytical Method Development and Validation in HHPLC and Dissolution.
- Project management and technical background.
- Understand FDA, EMEA, VICH/ICH regulations.