ANALYTICAL DEVELOPMENT CHEMIST
JOB PURPOSE
Perform analytical testing in line with regulatory guidelines and company policies to support technical operations, pharmaceutical development, and technology projects. Contribute to the development of robust pharmaceutical products, continuous improvement initiatives, and the support of existing commercial products.
KEY DUTIES AND RESPONSIBILITIES
- Support the analytical testing of drug substances, excipients, packaging materials, devices, drug products and drug-device combination products.
- Support the validation of analytical testing methods of drug substances and drug products at Millicent Pharma sites.
- Support the technical transfer of analytical testing methods of drug substances and drug products at Millicent Pharma sites.
- Support pharmaceutical technology projects supporting commercial products, primarily with respect to analytical testing.
- Support the development and manufacture of pharmaceutical dosage forms and drug product-device combination products.
- Support the preparation of regulatory filings such as INDs, ANDAs, NDAs and supplements.
- Stay current with emerging technology and regulatory guidance within industry.
- Ensure effective partnership with other areas in the Company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance.
- Represent Technical Operations group in internal and external (vendor) meetings and teleconferences in a positive, collaborative manner.
- Contribute to the review of company policies and procedures.
- Undertake any other duties, which may be assigned by Senior Management.
ESSENTIAL SKILLS
- Degree in Chemistry, Analytical Chemistry, Pharmacy or related equivalent (with strong Chemistry content). Masters degree or PhD preferred.
- At least 1 year of practical experience of working in an analytical laboratory performing analysis using HPLC/ UPLC. Experience of working in a GMP environment preferred.
- Knowledge of ICH guidelines relating to Analytical Method Validation.
- Understanding of quality control finished product and raw material testing.
- Practical knowledge of analytical testing of pharmaceutical solid oral dosage forms.
- Demonstrable IT skills i.e., Microsoft Word, Excel, PowerPoint etc.
- Knowledge and understanding of GMP aspects of laboratory software applications i.e., Empower.
- Proven communication skills (written and verbal).
- Proven ability to maintain high standards of work and attention to detail.
- Demonstrable planning, organization and time management skills.
- Must be able to work individually and as part of a team.
- Ability to work proactively and under time constraints.
All candidates must have the right to work in the United Kingdom on a permanent basis
