(Associate) Director, Analytics mAbs and Bioconjugation

Proclinical is seeking a dedicated and experienced (Associate) Director, Analytics mAbs and Bioconjugation. This role is focused on the development, qualification, and characterization of analytical tools required to support manufacturing, release, and characterization of biologics drugs and bioconjugates. The ideal candidate will be a motivated team player with strong organizational skills, eager to deliver quality assurance standards to early development projects.

Responsibilities:

• Development, qualification, and characterization of analytical tools for biologics drugs and bioconjugates.
• Development of potency and activity assays for transfer to CDMOs, including cell-based assays.
• Selection and establishment of assays and know-how transfer.
• Overseeing assay qualification, validation, and third-party vendors.
• Conducting developability assessments with biologics and bioconjugates, supporting formulation development.
• Responsibility for analytical methods used for quality control testing of product and batch release of drug substance.
• Supporting compilation of regulatory filings with respect to QC and stability.
• Overseeing external stability studies and maintaining internal data summaries for shelf-life definition.

Key Skills and Requirements:

• D. or Master degree in Biochemistry, Molecular Biology, Immunology, Chemistry, Bioengineering or related discipline.
• Experience in QC and analytical development.
• Experience with method development, optimization, qualification, validation, transfer, and investigation for biotherapeutics.
• Experience with complex methods for product characterization, such as MS, DLS.
• Experience with development of (cell based) potency assays.
• Familiarity with cGMP, ICH, USP and WHO guidelines on regulatory requirements for method qualification and validation.
• Ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods.

Interested or know someone who might be? Reach out to Antoine Mortiaux using the following:

✉️ a.mortiax@proclinical.com

📞 +33 188 888 168

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.