14 Oct
|
Kashiv BioSciences
|
Pune
14 Oct
Kashiv BioSciences
Pune
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 qualified bioanalytical experience within the biopharmaceutical, clinical research, or life sciences industry.
📌 Bioanalytical Manager / Scientist (Pune)
🏢 Kashiv BioSciences
📍 Pune