LSC have a great contract opportunity for a Manager Drug Substance, External Technical Services to join a biopharmaceutical company based in Dublin. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have minimum of four years' experience in providing technical support to Drug substance manufacturing (facility design, technology transfer or routine cGMP manufacturing) and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Act as subject matter expert for Drug substance processes, including technology transfer, process evaluation, problem solving and investigation.
o Work through collaborate within the organization to drive for results
o Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
o Provide expertise in trouble shooting activities to support manufacturing either on site or virtually
o Identify and lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
o Provide technical leadership and direction for transferring new products and processes. Lead risk assessments in support of new product implementation and provide direction and significant technical input for DFM (Design for Manufacturability) initiatives.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
o Minimum Bachelors' degree in Engineering (Chemical, Biochemical) or related field. Advanced degree would be an advantage.
o Good understanding of cGMP requirements for commercial Drug substance manufacturing, mammalian cell culture and purification unit operations.
o Experience of technology transfers and scale-up
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Siobhan Cummins at LSC on 021-4777329 if you have anymore questions about this Manager Drug Substance, External Technical Services opportunity!