Description
A global healthcare company is currently seeking a Senior Process Scientist to work in their new site in Dublin on the R&D team. 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.This organisation is passionate about innovation and commitment and is focused on hiring the best people. If you would enjoy working in an organisation with a culture of innovation and empowerment and like learning then this is the place to be! It is a busy and fast paced environment where your role will have a good scope for learning and development. An attractive salary and benefits package is on offer.
Day to Day:
*Work as a member of R&D with colleagues in Dublin and the UK and with commercial manufacturing, to ensure the successful technology transfer and on time file submission of an inhalation product to the US and EU.
*Compile, review, execute and report process development and clinical protocols to assure appropriate data for regulatory submissions and compliance.
This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale.
*Co-ordinate the compilation of technical components of the regulatory submissions.
*Prepare technical aspects of the regulatory submission for initial filing and for post approval changes and variations in the US and Europe.
*Author, and coordinate the completion of technical reports to support product submission filings.
*Document and coordinate the investigation of product performance issues.
*Coordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results.
*Execution of process development/demonstration or validation studies and write-ups.
Requirements:
*The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who
wants to progress in a fast paced environment.
*Science / Engineering qualification (minimum of degree), with 3 years relevant experience in Technology Transfer, Tech Services or Process Development.
*High proficiency in Microsoft Excel/Powerpoint/MS Project etc.
*Previous experience with new product introduction and technology transfer required.
If you are interested in this great opportunity please contact me Anna Mooney or apply below with an up to date CV.