Senior Development Chemist - Formulation
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.
- Independently participates in aspects of experimental design to determine the final formulation component and/or process selection (direct compression, wet/dry granulation).
- Performs hands-on formulation design, development and optimization experiments such as blending, granulation, milling, tablet compression, film coating etc.
- Troubleshoot formulation issues that occur during product development, scale-ups, tech transfer and/or in manufacturing
- Determine key API and/or formulation properties e.g. pKa, pH, solubility, disintegration, dissolution, etc.
- Assesses the chemical and physical stability of formulations in collaboration with the analytical team and to identify the root cause of potential stability, manufacturability and performance issues.
- Manages relationships and output of internal and/or contract labs that would be carrying out various development activities on company's behalf.
- Provide technical supervision and mentoring to peers
- Writes Chemistry, Manufacturing and Control (CMC) section for Regulatory submission.
- Independently authors and approves technical documents, such as protocols, technical reports, batch records, test methods, and operating procedures
- Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements.
- Will hold a minimum of 5 years of experience in oral solid dose pharmaceutical formulation
- Knowledge and hands on experience in oral solid dosage form development and manufacturing including low/high-shear granulation, fluid-bed technology, roller compaction and compression in a GLP GMP based Pharmaceutical setting.
- Working knowledge of regulatory requirements, including MHRA, FDA, EMEA, ICH and VICH regulations
- Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow