Job Summary:
Assistant General Manager in Advanced analytical technologies laboratory for Biosimilar/novel biologics/CDMO development would be responsible for defining and executing analytical strategies across the entire development lifecycle.
The position shall manage a group of scientists and analysts, ensuring high-quality scientific execution, resource planning, and talent development.

Role & Responsibilities:
Key responsibilities include overseeing analytical method development, qualification, validation, transfer, and lifecycle management.
The role shall get involved comprehensive bio similarity assessments by comparing structural, physicochemical, and functional attributes of biosimilars with reference products.
The individual provides expertise in advanced analytical techniques such as HPLC/UHPLC, CE-SDS, cIEF, LC-MS, peptide mapping, glycan analysis, and Gel based assays.
The role would support identification and monitoring of critical quality attributes (CQAs) and establishes analytical control strategies for product development and manufacturing.




Close collaboration with process development, formulation, manufacturing, quality, regulatory, and clinical teams is essential to ensure successful project delivery.
Prepares and reviews analytical reports of regulatory submissions and supports interactions with global regulatory agencies.
The individual should be well versed with GLP, Data management, Compliance and ALCOA++.
The position will be responsible for data interpretation, reporting, regulatory compliance, and management of external laboratories and clients.
Leadership, communication, stakeholder management, team collaboration, problem-solving, decision-making, strategic thinking, adaptability, conflict resolution, emotional intelligence, mentoring and coaching, time management, negotiation, accountability, resilience, and interpersonal skills.
Candidates should hold a Ph.D. with 7-8 years of experience or M.Sc. plus 15-20 years of experience in a rel

📌 AGM- Advanced Analytical Technology (India)
🏢 Enzene Biosciences
📍 India