JOB TITLE: 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 / 5 S / 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.