Opportunity for a product development chemist with a pharmaceutical background to join this well regarded sterile manufacturer
Exciting opportunity to be part of the R&D team of this highly regarded manufacturer of sterile pharmaceutical products.
Working in a dynamic manufacturing environment this role interfaces with all key stakeholders including regulatory, quality, production and validation teams.
Professional, team-based environment and reporting through to the Product Development Manager you will be responsible for the following:
- Develop new products and optimise existing products
- Establish project timelines for the development of each new product
- Generate all required development and stability data for new products
- Registration of new products
- Develop manufacturing processes to ensure successful scale-up from bench scale to pilot batches to commercial batches.
- Lead technical transfer from R&D to commercial manufacturing environment.
- Assist with test method development for new and existing products where required.
- Training and mentoring Product Development Chemists
- Generate required CMC information
- Ensure the successful registration on Marketing Authorisation/variation approvals
- Training of production operators
- Relevant tertiary qualifications
- Experience gained working in a NPD role ideally in a sterile manufacturing facility
- Sound Chemistry background
- Permanent residence/Citizen visa status