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Bioanalytical Manager / Scientist

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Onsite

Bioanalytical Manager / Scientist

Kashiv Biosciences

Bioanalytical Manager / Scientist

Skills

Testing & QAComplianceRegulatory Compliance

18 days ago

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Important information


Contract type:

Permanent

Location:

Pune, Maharashtra, India

Work mode:

Onsite

Published on:

13 October 2026

What they need


Job highlights

  • M.Sc./M.Pharm/M.Tech/Ph.D. in Life Sciences with 4-8 years bioanalytical experience
  • Oversee development, validation, and analysis of PK, PD, ADA, and NAb assays; review protocols and ensure regulatory compliance

Relocation Note: This position is based in Ahmedabad. Candidates must be willing to relocate to Ahmedabad, Gujarat.

We are seeking an experienced Bioanalytical Manager to oversee complex bioanalytical operations, method development, validation, and sample analysis supporting pharmacokinetic (PK), pharmacodynamic (PD), anti-drug antibody (ADA), and neutralizing antibody (NAb) assays. This role requires rigorous technical oversight and quality review of bioanalytical data to ensure compliance with regulatory and clinical standards.

Key Responsibilities

  • Oversee the development, validation, and sample analysis for pharmacokinetic (PK), pharmacodynamic (PD), anti-drug antibody (ADA), and neutralizing antibody (NAb) assays.
  • Review bioanalytical protocols, standard operating procedures (SOPs), analytical runs, and final study reports.
  • Ensure strict adherence to regulatory guidelines, data integrity, and quality assurance principles in all bioanalytical documentation and laboratory operations.

Key Requirements & Qualifications

  • Education: M.Sc., M.Pharm, M.Tech, or Ph.D. in Biotechnology, Biochemistry, or related Life Sciences.
  • Experience: 4 to 8 years of professional bioanalytical experience within the biopharmaceutical, clinical research, or life sciences industry.

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