Senior Development Chemist - Analytical
Location: Keighley, Yorkshire
Salary: Competitive, depending on experience
Reports to: Pharmaceutical Development Manager
Our Client- A global Pharmaceutical Company are looking to appoint an experienced Development Chemist who will work as a vital part of the Development team and provided with a competitive package and furthered career scope.
- 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
- Troubleshoots analytical issues that may occur during product development, validations, manufacturing processes, tech transfer/scale-up.
- Development of suitable and robust methods based upon quality by design (QBD) concepts that address critical quality attributes and process parameters.
- Set and justify drug substance and drug product specifications with the understanding of clinical study design and CMC process.
- Develop, validate and transfer (as applicable) analytical methods, suitable for progressive stage of pharmaceutical development.
- Timely monitoring and evaluation of release and stability data for GMP compliance, potential out of specifications, out of trend, and method performance issues, conduct investigations and implement corrective actions as needed.
- Manages relationships and output of internal and/or contract labs that may be carrying out various development activities on company's behalf.
- Provide technical guidance in analytical activities to (junior) colleagues.
- Assists in the preparation of Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission.
- Will hold a Degree in a relevant/ Science discipline
- Will have extensive GLP GMP industry experience using HPLC, LC-MS, GC, GC-MS, FT-IR, UV-vis, Karl Fischer and physical characterisation of API and final dosage forms); this needs to be in a commercial or manufacturing lab (not education based).
- Must have significant experience required in analytical method development and validation (as a minimum in HPLC and dissolution)
- Working knowledge of regulatory requirements, including FDA, EMEA, VICH/ICH regulations