Description
A global healthcare company is currently seeking a Scientist to work in their new site in Dublin. It is an exciting growth phase for this organisation and there is significant expansion plans. The scale of expansion and investment is extremely significant. Being part of this organisation at this time will provide you with a sense of achievement and opportunity to really make an impact. You will get great exposure to cutting edge systems and will get to see the product right through to market.Day to Day:
- Provide leadership to analytical team. Schedule weekly testing within the Analytical Control and Development Laboratory in line with project plans and agreed timelines as required. Ensure testing and release of development, clinical and scale up batches in line with required GMP practices and quality procedures.
- Work with the stability group within the company to design and execute stability protocols that meet regulatory requirements to support shelf life assignment for clinical studies and commercial product. Schedule stability testing and review and approve stability testing to meet study timelines.
- Work with cross functional teams within the company to provide analytical support for all pilot plant activities. These cross functional activities include product development, environmental monitoring, cleaning validation, device testing and material release.
- Review and approval of release documentation for components, API, excipients and finished product. Deputise for the laboratory manager as required.
Requirements:
- 6+ years' experience in an analytical role within the pharmaceutical sector in a FDA or IMB accredited laboratory
- Strong technical Leadership skills and ability to provide technical direction and coach more junior analysts
- Strong Technical writing skills with respect to regulatory filings and technical protocol/report writing
- Experienced in interpretation of analytical data including basic statistical analysis
- Strong and innovative problem solving skills
- An understanding of the requirement to meet project and team orientated goals and the ability to create win-win relationships with other functions to meet these goals.
- Excellent interpersonal communication skills with the ability to interact effectively at all levels within the organisation
To hear more about the role and company please contact me Anna Mooney or apply below with an up to date CV.