Our client's Bioanalysis and Immunogenicity team within the DMPK department is searching for a (Sr) Scientist to join a team developing and running custom ligand-binding assays for research and development purposes. Assay applications will include pharmacokinetic (PK), immunogenicity (ADA) and biomarker (BM) assays in a non-regulated setting as well as oversight of transfer to and execution of assays at regulated labs for studies. This role will be 100% onsite in Cambridge, MA.

Key Responsibilities Include:

• Scientific responsibility for PK and immunogenicity bioanalysis in non-regulated settings
• Design, develop and validate PK, BM and/or ADA assays
• PK, BM and immunogenicity analysis to support in vivo studies
• Transfer assays and monitor bioanalytical studies internally to other global R&D sites or externally to CRO partners
• Report and discuss bioanalytical and biomarker results with integrative knowledge of how the data contributes to the drug development process
• Manage bioanalytical sample inventory, laboratory chemicals, supplies, and ancillary equipment
• Assist purchase order generations

Education & Experience:

• PhD in a life sciences field that includes immunoassay development (e.g. biochemistry, immunology, biology, etc.); or MSc, with 2-4years or BS with 4-6 years of relevant experience.
• Strong background in immunoassay development using technologies such as ELISA, MSD, Gyros, SIMOA, etc.
• Strong knowledge of immunogenicity and principles of bioanalysis: familiarity with current bioanalytical and immunogenicity regulatory guidance (FDA/EMA/ICH) is a plus
• Quality-oriented - Prior experience in a regulated bioanalytical laboratory (GLP/GCP/GCLP) is a plus.
• Experience with method development and bioanalytical assays is required.

Additional Key Skills:

• Softmax Pro and/or Watson Lims
• Experience with MSD, Gyros or Quanterix would be a plus!
• Excellent time management, organization skills and communication (verbal, written, interpersonal, listening) skills.
• Ability to work independently with minimal supervision.
• Ability to adapt to rapidly changing priorities and multi-task to meet timelines in a fast-paced environment.
• Ability and willingness to work in a laboratory
• Team player
• Excellent English skills (oral and written)
• Knowledge of MS Office (Word and Excel)

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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