Role
Associate Director, Translational Bioanalytical Sciences, leading regulated LC-MS/MS bioanalytical activities supporting small molecules, oligonucleotides, and biologic therapeutics, primarily for small molecule programs.
Responsibilities
- oversee method development, validation, and sample analysis across clinical stages;
- manage CROs and internal teams;
- provide scientific leadership on assay strategies;
- participate in study design, regulatory documentation, and vendor governance;
- contribute to regulatory meetings with agencies like FDA and EMA.
Requirements
- PhD or MS in Analytical Chemistry, Chemistry, or Biochemistry;
- minimum 10 years’ post-doctoral experience in pharmaceutical bioanalysis focusing on small molecules and oligonucleotides;
- expertise in LC/MS method development, validation, and GxP compliance;
- strong understanding of regulatory standards (FDA, EMA, CLSI).
Nice to Have
knowledge of additional biological assay techniques and LIMS systems.
High-Value
focus on small molecules and oligonucleotides, regulated bioanalytical work aligned with IND-enabling and clinical development stages, GxP environment, and cross-functional collaboration.
Work setup
hybrid role based in (City, Country), with 5–15% travel.
#J-18808-LjbffrAssociate Director, Translational Bioanalytical Sciences in bridgewater at Unknown Company
This position is listed as full time and hybrid.