Associate Principal Scientist, Analytical R&D

Job Description

We are looking for an Associate Principal Scientist to join our team in Dublin Biotech. In this role, you'll become a global expert in bioassays, enzyme-linked immunosorbent assays and cell-based assays. You will report directly to the Director of Bioassay Global Laboratories and play a vital role in supporting our global network.

As a key member of our team, you will provide on-site analytical support at both internal and external testing labs, ensuring effective technical oversight of crucial analytical testing. Your involvement will span the late-stage development, transfer and management of analytical methods for our large molecule pipeline.

Your responsibilities will include:

• Leading Analytical SME for ELISAs and cell-based potency assays, with deep scientific understanding of all bioassay methods used for release of biological products.
• Supporting scientists across various sites and managing the transfer of analytical methods.
• Overseeing the lifecycle of analytical immunological methods for vaccines and biologics.
• Implementing continuous improvements in bioassays and resolving analytical issues.
• Leading investigations into analytical problems to ensure test result accuracy and reliability.
• Contributing as an author and reviewer for regulatory submissions, as well as supporting audits.

What We’re Looking For:

• A Master’s or Ph.D. in Biological Sciences, Biochemistry, Biochemical Engineering or related fields.
• At least 6 years of relevant experience with immunological and cell-based analytical methods.
• Strong project management skills and a proven track record in managing complex projects and investigations.
• A solid understanding of relevant regulatory and quality guidelines (GMP, ICH, USP) and knowledge of CTD format for IND/BLA/MAA submissions.
• Excellent analytical and technical skills, with a self-starting, innovative mindset.
• Ability to collaborate effectively across a global organization and meet tight deadlines.
• Skills in identifying and communicating risks effectively.

Additional Details:

• This is a hybrid position, requiring a minimum of 2-3 days on-site based on analytical support needs.
• Up to 25% travel may be necessary.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.