Job Description
Job Title: Senior Process Engineer, New SM API Products
Small Molecule (SM) Active Pharmaceutical Ingredients (API) manufacturing is changing with the pipeline of the future including molecules of increasing complexity (such as ADC’s and macrocyclic peptides), lower volume and higher potency products and increasing utilisation of new and sustainable technologies such as flow chemistry, continuous manufacturing, photo and biocatalyst driven chemical synthesis. To enable this change the company are investing in flexible facilities and infrastructure with small-scale trains for multiproduct commercialisations for low volume / high potent API as well as future specialised skids for new technologies. The facilities will manufacture APIs for late phase clinical, launch and early commercial supply using both batch and continuous manufacturing technology.
A new position has arisen in our growing Commercialisation, Development and Supply (CDS) team for a Senior Process Engineer, new small molecule API Products. This role provides exciting and challenging opportunities to work on multiple API projects, ranging from manufacturing support activities to late-stage clinical product development and scale-up, new product introductions and technology transfers across our existing and new facilities of the future.
What you will do:
Work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones. Bring energy, knowledge and passion about science and technology to carry out the following:
Lead engineer on new product introductions and/or technical transfers to and from the site, including new technologies.
Co-develop new SM API products with Research and Development partners globally.
Direct day-to-day project development plans.
Provide knowledge and subject matter expertise on API processing unit operations and scale up to colleagues in Quality, Supply Chain and Manufacturing Operations.
Evaluation of raw materials, development of process fits, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring and cycle-time studies, deviation investigations and resolution, and development of filing strategies.
Key attributes: Dedicated, unswerving, approachable and reliable.