16 Sep
|
Talental Consultings
|
Navi Mumbai
16 Sep
Talental Consultings
Navi Mumbai
Job Description – Manager/ Sr. Manager - Microbiology | Biosimilars, mAbs & Peptides
Job Summary:
Lead microbiology activities supporting biosimilars, monoclonal antibodies (mAbs), and peptide manufacturing, ensuring robust microbiological control and GMP compliance.
Key Responsibilities:
Manage microbiological testing of raw materials, process samples, finished products, water and utilities.
Oversee bioburden, endotoxin, sterility, microbial identification, and environmental monitoring activities.
Review microbiology data, OOS/OOT, deviations, investigations, CAPA, and change controls.
Ensure compliance with GMP, data integrity, pharmacopoeial and regulatory requirements.
Support method validation/verification, contamination control, audits, and regulatory inspections.
Lead, mentor, and develop the microbiology team and drive continuous improvement.
Experience: 10+ years
Qualification: M.Sc./M.Tech.
in Microbiology or Life Sciences
Required Skill Profession
Other General
📌 Manager/ Sr. Manager Microbiology (Biologics) (Navi Mumbai)
🏢 Talental Consultings
📍 Navi Mumbai