Associate Scientist/Analyst is required for a leading Biopharmaceutical company in Cork. The facility is a strategic manufacturing centre in the global supply chain for many of the company’s existing and new pipeline Biotechnology products. The facility includes bioreactors of commercial scale and clinical scale along with the associated class 100,000 cleanroom, media preparation and downstream processing and separation facilities.
The Associate Scientist/Analyst will:
o Overall release and stability management of product(s) according to portfolio: Evaluate chemical and physical trends. Assist in drawing conclusions on shelf-life, retest period and storage instructions under the guidance of the Scientific Integrator.
o Participate in projects as single point of contact building product stability expertise.
o Takes Lead on critical Lab Continuous Improvement projects and/or serve as representative on cross functional/Process teams.
o Write SOP’s, protocols, reports and IMPD/IND regulatory filing documents.
The Associate Scientist/Analyst requires:
o Bachelor’s degree in Biology, Pharmacy or related scientific field is required
o At least 3 years experience is required.
o Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
o Practical analytical laboratory experience in a GMP environment is required.
Call Amparo in LSC on 021 4777 329 to discuss this new Associate Scientist/Analyst role in more detail or apply directly via this advert.