Associate Scientist Outsourcing
Our client, a medical device company in Cork are currently looking to recruit an Associate Scientist Outsourcing for their site.
Main Duties and Responsibilities
- Support PDMS-CRS outsourcing initiatives in relation to outsourcing processes and technology team knowledge.
- Responsibility for data interpretation/trending on assigned role/technology.
- 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.
- Drive laboratory investigations in a comprehensive and timely manner.
- Implement outsourcing process improvements via Change Control/Change Management, where applicable.
- Review of clinical stability, characterization and release samples, as required.
- Ensure laboratory activities are carried out in compliance with cGMP and appropriate regulatory standards.
- Represent PDMS-CRS Cork where appropriate in meetings with leadership, stakeholders and outsourcing partners.
- Independently write/revise SOP's or other official documentation and reports, when required.
- Execute independently and/or as part of a team, assigned projects/tasks.
- Keep up to date with existing and new SOP's and official documentation.
- Participate in regulatory and internal audits as required.
- Perform other duties as designated by PDMS-CRS Management.
- Build forecasting tools for outsourcing requirements.
- A minimum of Degree in Chemistry, Biochemistry, Pharmaceutical Sciences or equivalent through experience.
- Knowledge of Separation technologies and/or Bioassay.
- A minimum of 3 years' experience within the pharmaceutical industry.
- Experience in 'large molecule' analytical technology.
- Project management.
- Problem solving and attention to detail are critical skills.
- Customer focus and result driven.
- Efficient, flexible and dynamic.
- Excellent communication skills.
- Work effectively with people that have diverse styles, talents and ideas.
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