Associate Scientist Outsourcing is required for a leading pharmaceutical company in Cork. Our client specialises in the manufacture of small molecule APIs in three production facilities on site, one of which is sterile. This site has been producing APIs for over 35 years in Cork and has developed a reputation as being innovative, adaptive and having a clear strategic vision. The site has added to its core functions over the years and is now a key decision maker in the company’s global supply chain. The site is going through a series of upgrades and investments in 2016/17 which will add to its current capabilities and strengthen its long term strategic plan.
The Associate Scientist will be responsible for:
o Support PDMS-CRS outsourcing initiatives in relation to outsourcing processes and technology team knowledge.
o Responsibility for data interpretation/trending on assigned role/technology.
o Collaborate with the PDMS-CRS technology teams in relation to platform/non platform methods outsourced to provide the necessary information/issue resolution to the contract laboratories.
o Drive laboratory investigations in a comprehensive and timely manner.
o Implement outsourcing process improvements via Change Control/Change Management, where applicable.
o Review of clinical stability, characterization and release samples, as required.
o Ensure laboratory activities are carried out in compliance with cGMP and appropriate regulatory standards.
o Represent PDMS-CRS Cork where appropriate in meetings with leadership, stakeholders and outsourcing partners.
o Independently write/revise SOP’s or other official documentation and reports, when required.
The Associate Scientist requires:
o A minimum of Degree in Chemistry, Biochemistry, Pharmaceutical Sciences
o Knowledge of Separation technologies and/or Bioassay.
o A minimum of 3 years’ experience within the pharmaceutical industry.
o Experience in ‘large molecule’ analytical technology.
o Project management.
Call Amparo in LSC 021 4777 329 for more details on this new Associate Scientist role or apply directly via this advert.