AGM- Advanced Analytical Technology (Biosimilars)

Enzene Biosciences Ltd; Pune District; On-site; INR 4,200,000 - 6,600,000; Full time

Job summary

Enzene Biosciences Ltd. in Pune is seeking an Assistant General Manager to lead the Advanced analytical technologies laboratory for biosimilar/novel biologics/CDMO development.

You will define and execute analytical strategies across the development lifecycle and manage a team of scientists. Role involves overseeing method development/validation, biosimilarity assessments, and collaboration with multiple functions to ensure project success.

Qualifications

• PhD with 7-8 years of experience or MSc with 15-20 years in biologics/biosimilar development.
• Expertise in analytical method development, validation, transfer and lifecycle management.
• Strong regulatory exposure and GLP/data integrity understanding.

Responsibilities

• Oversee analytical method development, qualification, validation, transfer and lifecycle management.
• Lead biosimilarity assessments comparing biosimilars to reference products.
• Provide expertise in advanced analytical techniques (HPLC/UHPLC, CE-SDS, cIEF, LC-MS, peptide mapping, glycan analysis).
• Support CQAs identification and analytical control strategies for development and manufacturing.
• Collaborate with process development, formulation, manufacturing, quality, regulatory, and clinical teams; prepare regulatory submissions.

Skills

Leadership

Regulatory compliance

Project management

Communication

Problem solving

Bioanalytical expertise

Education

PhD in a relevant field

MSc in a relevant discipline

Tools

HPLC/UHPLC

CE-SDS

cIEF

LC-MS

Peptide mapping

Glycan analysis

Gel based assays

Job description

• 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 relevant scientific discipline with significant experience in biologics or biosimilar development, including leadership and regulatory exposure.