Key Role Responsibilities:
- Formulates new products from development to commercialisation within company, industry, regulatory parameters and prepare product registration documentation and product chemistry packages to support new drug submissions; Pharmaceutical process development and optimisation of new pharmaceutical/bio equivalent liquid and semi-solid formulations.
- Changes existing formulations to improve product cost, quality, sourcing and evaluating raw materials for products.
- Participates in team driven activities to facilitate on going production improvements or new product development projects. Establishes specifications for new and/or reformulated product and creates formula dockets and SOPs for transition to larger scale manufacturing and pilot tests.
- Conducts patent searches to determine freedom to operate with a new formulation.
- Develops new technologies related to pharmaceutical processing.
- Lead problem-solving and trouble-shooting activities (scientific, equipment, process) related to product development
- Communicates and collaborates effectively with the cross functional departments and CMOs to support tech transfer and process validation activities
- Creates Project Timelines in accordance with marketing priorities, sets milestones/critical path and ensures on time project completion
- Documents analytical test results as they occur in logbooks and in-process test data in Production dockets as required.
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
- 1-2 years of drug formulation experience in a manufacturing environment, Experience with ANDA, IND, and INAD submissions
- Bachelor of Science in Chemistry
- Experienced in process development, optimisation and tech transfer of liquid and semi-solid dosage forms. Basic HPLC and GC techniques, Strong understanding of cGMP guidelines, FDA and EU regulations related to the pharmaceutical industry
- High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative and effective communication.
- Masters Degree in Science or PhD in Chemistry
- Exposure to Lean Six Sigma and QbD methodologies