JOB TITLE:Analytical Development Chemist DEPARTMENT:Technical Operations REPORTING TO:Associate Director Technical Operations JOB PURPOSE Perform analytical testing to support Pharmaceutical Development and Pharmaceutical Technology projects. Work to be performed in accordance with the appropriate regulatory guidelines and company policies. Support pharmaceutical development projects, primarily with respect to analytical testing, to ensure the development of robust pharmaceutical products. Support pharmaceutical technology and continuous improvement projects, primarily with respect to analytical testing, and to support existing commercial products KEY DUTIES AND RESPONSIBILITIES Support the analytical testing of drug substances, excipients, packaging materials, devices, drug products and drug product-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. LEARNING & DEVELOPMENT Actively engage in an individual development / personnel improvement plan. Actively engage in the continuous improvement / 5S / 6 sigma programme. Ensure training has been received in relation to specific duties. HUMAN RESOURCE MANAGEMENT Adhere to the Companys policies and procedures. HEALTH & SAFETY Understand and follow the companys Health & Safety policies. Comply with the environmental management system and minimise environmental impact where possible. QUALITY Comply with all aspects of the Millicent Quality System. Ensure that a quality culture and an appreciation of the quality system is installed within the manufacturing department. CORPORATE All employees are expected to work towards the company vision and adhere to the core principles of building strong teams of empowered people, communicating effectively, demonstrating trust and respect, developing peoples knowledge and expertise, demonstrating excellence in leadership and exhibiting a positive attitude. This job description should not be regarded as conclusive or definite. It is a guideline within which the individual job holder works. It is not intended to be rigid or inflexible and may alter as the companys strategic direction changes. Personnel Specification 1. Educational Attainment Essential: Degree in Chemistry, Analytical Chemistry, Pharmacy or related equivalent (with strong Chemistry content). Desirable: Degree in Chemistry, Analytical Chemistry, Pharmacy or related equivalent at 2.1 or higher. Masters Degree in Chemistry or related equivalent. PhD in Chemistry or related equivalent. 2. Job Experience and Training Essential: At least 1 year's practical experience of working in an analytical laboratory. Knowledge of ICH guidelines relating to Analytical Validation. Understanding of quality control finished product and raw material testing. Desirable: At least 3 years' practical experience of working in an analytical laboratory and GMP environment. At least 1 year's practical experience of Analytical Method Development and Analytical Method Verification / Validation / Transfer (HPLC/UPLC). 3. Specialist Knowledge Essential: Not applicable. Desirable: Practical knowledge of at least one of the following techniques: Water Content (LoD and KF) Gas Chromatography FTIR Particle Size Distribution by Laser Diffraction Viscosity / Rheology 4. Special Skills Essential: Demonstrable IT skills (e.g., Microsoft Word, Excel, PowerPoint). Knowledge and understanding of GMP aspects of laboratory software applications (e.g., 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. Desirable: Knowledge and direct experience in using Empower software. Knowledge and understanding of statistical software applications (e.g., MiniTab). 5. Disposition Essential: Must be able to work individually and as part of a team. Ability to work proactively and under time constraints. Desirable: Good interpersonal skills.