Associate Scientist X 2 (Contract, Cork)
CAREERWISE RECRUITMENT
CORK
ASSOCIATE SCIENTISTS (LATE DEVELOPMENT & STABILITY SCIENCES) x 2 required by CareerWise Recruitment for our BioTech client in Cork, 10 month maternity leave cover contract and initial 12 month contract on offer. The ASSOCIATE SCIENTISTS (LATE DEVELOPMENT & STABILITY SCIENCES) will report to the Senior Scientist, Late Development and Stability Sciences and will participate and lead on various projects, analytical techniques and testing issues in support of clinical release and stability testing. THE ROLE: * Apply analytical knowledge to interpretation of generated data and ensure high quality of the delivered results working with senior colleagues. * 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. * Participate in projects as single point of contact building product stability expertise. * Takes Lead on critical Lab Continuous Improvement projects and/or serve as representative on cross functional/Process teams. * Write SOP's, protocols, reports and IMPD/IND regulatory filing documents. * Proactively identifies and drives process improvements. * Acts as subject matter expert on assigned analytical techniques. * Presents technical analytical data clearly and concisely to customers, i.e., internal and external regulatory inspections. * Keeps abreast of analytical technology and compliance trends. * Execute assigned NME transfer programs and related projects. REQUIREMENTS: * A minimum of a Bachelor's degree in Biology, Pharmacy or related scientific field is required. * At least 3 years experience or related post graduate academic experience is required. * Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. * Practical analytical laboratory experience in a GMP environment is required. Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.
1555 days ago