Telephone: 086 0468858
Analytical Support Scientist
Our client, a pharma company in Cork and Carlow is currently looking to recruit an Analytical Support Scientist for their site.
Analytical Support Scientist
- The Analytical Support Scientist has responsibility for all aspect of analytical support through development, clinical and commercial stage of new Drug Products. This involves method development and validation, testing of clinical materials and support to launch of the product. The Analytical scientist may also support improvement initiatives in any area of the analytical development business.
- The Analytical development scientist is responsible for ensuring all analytical activities comply with cGMP. She/he assures compliance with all safety and environmental requirements.
- Supports/leads the development and optimization of reliable, validated, analytical methods to characterize the quality attributes of drug substances and products for all projects supported by Carlow. She/he is responsible for testing of drug substances and products to be used in post-proof of concept clinical supplies.
- Assures that appropriate information on the quality of excipients and in-process control points is provided to support process optimization studies with a clear linkage to Quality by Design and regulatory filing requirements. In conjunction with the stability group, determines the appropriate expiry dating for each drug product.
- Contributes to the development of appropriate specifications for assuring the quality of drug substances and products throughout the expiry period and for inclusion in the CMC sections of IND amendments and WMA/NDS submissions. She/he provides the analytical CMC information for filings and responses to queries from worldwide regulatory agencies in connection with this information to support marketing approvals.
- Leads the transfer of analytical methods, specifications and development knowledge for the drug substance and product. Establish relationships with key Supply and outsourcing partners that facilitate a clear understanding of analytical issues and product timelines. Continually executes the analytical elements of project to assure attention to critical issues and appropriate resourcing (by supporting functions) to meet project needs and timelines. In conjunction with the analogous areas in Supply establishes clear expectations regarding method transfer information content and logistics.
- Support supply operations as required in a timely manner to resolve analytical issues and assure continue flow of material.
- In partnership with the Quality organization, formulates and continually updates appropriate GMP procedures for the group.
- Maintains outside contacts in the scientific community, universities, government and other outside laboratories in relation to analytical chemistry. Monitor industry trends, new technology initiatives and worldwide analytical regulatory guidance.
- This position requires a B.Sc. (or equivalent experience base) in analytical biochemistry pharmaceutical science or a related discipline and a minimum of 5 years experience in analytical biochemistry or a related pharmaceutical drug development area or a PhD in analytical biochemistry or associated disciplines.
- The incumbent must have demonstrated problem solving, communication and people management skills.
- Strong scientific understanding of analytical methodology, process optimization support needs and knowledge of relevant regulatory requirements, including GMPs is important.
- Expertise in analytical laboratory techniques
- Team work skills
- Skills in leading defined projects
- Computer skills - excel, word, outlook, scheduler,
- Project Management Skills
- Interpersonal Skills Customer Service skills
- Written & verbal presentation and communication skills
- Time management.
For further information on this Analytical Support Scientist role in Cork or Carlow please contact Nick on 086 0468858/ email@example.com
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