Bioassay Scientist Westport
We are now recruiting a Bioassay Scientist to join our clients diverse Biologics Development team in Westport on a 24 month-year fixed-term contract basis. The Bioassay Scientist will work along side Scientists and Specialists focused on continuous improvement initiatives for complex Bioassays. The Scientist will be responsible for Bioassay method transfers and qualification in the Westport facility, and will work closely with the commercial cell-based potency assay team to ensure all necessary criteria and procedural controls are implemented to achieve success.
So, what do you need to do this role?
- As Bioassay Scientist, you will support Bioassay Method Transfer and qualification
- You will guide efforts to ensure Implementation of procedural controls
- As Bioassay Scientist, you will lead and/or coordinate technology transfer activities for complex Bioassay(s).
- We believe in collaboration so in this role you will be involved in cross functional collaboration and method filings for product
- As part of this diverse and inclusive team, you will perform Data analysis and presentation as part of your work
- You will hold a Bachelor’s degree in a Biologics related discipline
- You will have 2+ years’ work experience specializing in commercial & / or clinical Bioassay/ Analytical testing
Technical Skills and Experience:
- Excellent technical writing and communication skills.
- Proven ability to problem-solve.
- Biologics experience and understanding of Bioassay and Bioanalytics (CBPA, HPLC, ELISA, Western Blot etc.)
- Has participated in process and quality risk assessments.
- Has lead and/or coordinated technology transfer activities for complex Bioassay(s).
- Understanding of Reference Standard qualifications.
- Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
- Experience with GMP regulatory inspections.
- Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements.
- Strong leadership and people development skills.
- Strong communication skills required to deliver on cross-site goals and objectives
For a confidential discussion and more information on the role please contact Chris O Toole.