Bioanalytical Program Lead

10 - 15 years

25 - 40 Lacs

Posted:3 weeks ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  • Collaborate closely with laboratory-based scientists and provide support in experimental design as needed.
  • Leverage scientific expertise while engaging with a diverse set of collaborators and cross-functional teams.
  • Interface with regulatory agencies and health authorities across multiple countries.
  • Manage risk, prepare and submit regulatory documents, and respond to inquiries from health authorities.

Preferred candidate profile

  • Recognized Subject Matter Expert in regulated bioanalysis across multiple modalities including PK/CK, PD, and immunogenicity assessments (humoral and cellular).
  • Proven experience as a bioanalytical lead within diverse project teams, defining and implementing robust bioanalytical strategies to advance the portfolio.
  • Strong expertise in small molecule and peptide bioanalysis using LC-MS.
  • Hands-on experience in regulated bioanalysis for multiple drug modalities.
  • Demonstrated publication and presentation record in the field.
  • Exceptional verbal and written communication skills.

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