LSC have a great contract opportunity for a Downstream Technical Specialist to join a Multinational Pharmaceutical Company based in Dublin.
If you have 8 years+ experience in a pharmaceutical manufacturing organization and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provide process information and expertise to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer startup, PPQ validation, launch and continual improvement of existing and future products in a multi-product BDS facility.
o Provide technical direction and provide SME oversight in an area of BDS manufacturing; (mammalian cell culture/downstream purification), be the company SME (Cell Culture) to develop and defend technical rationale during regulatory audits and inspections.
o Provide scientific and technical input to facilitate decision making.
o Provide input and engage with Product Lifecycle Management (PLCM) of company products.
o Identify technical issues, improvement initiatives and guide resolution/completion of same.
o Possess deep technical knowledge and understanding in BDS manufacturing processes; (mammalian cell culture/ downstream purification operations, cause and effect, scale up principles, QRM, process validation strategies) and apply and build on the company’s product portfolio.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Minimum undergraduate degree in chemistry, biology, engineering or related discipline
o Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations, process/facility fit, New Product Introduction Technology Transfer
o In-depth technical & operational knowledge of unit operations in cell culture processing, centrifugation, depth filtration.
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!
To apply, submit your CV via this advert or contact Ruth Holland at LSC on 021-4777329 if you have anymore questions about this Downstream Technical Specialist opportunity!