Process Scientist

Job Description

A new opportunity has arisen for an experienced Process Scientist to join a successful team with a multinational pharmaceutical company.

The Development Scientist works as part of the global MSAT team in the Manufacturing Technologies and Industrialisation (MT&I) department as a technical leader providing support to technology transfers for clinical and commercial products, New Product Introductions and commercial operations at the Waterford Facility and within the global Sanofi network as required.

As part of the MT&I team

• Provide product and technical leadership to cross functional teams for tech transfer programs through scale up, for clinical & commercial product transfer for lyophilised drug products
• Provide technical leadership & critical analysis of product during technology transfer & product lifecycle management
• Develop data driven strategies for process development / product characterisation
• Provide product governance for established commercial products for new process & technology improvements, and operational support from drug products
• Lead product investigations with strong understanding of compliance and cGMP, strong scientific judgement and leadership in decision making
• Write, review and approve technical reports

 

About you

To excel in this role you will need to be a highly motivated individual to function as a key member of the MSAT group

• B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences, Pharmaceutical Science, Engineering or equivalent
• Demonstrated experience in identifying and resolving complex technical issues
• Strong technical writing and communication skills
• Solid working knowledge of cGMP's, GDP, GLP etc.
• 2- 5 years in a cGMP biologics or pharmaceutical manufacturing setting
• or in lieu of experience equivalent Ph.D or M.Sc. experience
• It would be advantageous to have (not essential):

• Ph.D or M.Sc. in the relevant field would be advantageous
• Experience with aseptic fill finish technology platforms such as formulation, sterilisation, lyophilisation, isolators, filling machines
• Experience in Technology Transfers
• Good knowledge of statistical techniques in the use of problem solving data analysis
• Understanding of the key quality attributes and influencers of physical and chemical stability of biologics based drug products

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.