AGM- Advanced Analytical Technology (Biosimilars)
Enzene Biosciences
- Location
- Pune District, Maharashtra, India
- Job type
- Full-time
Required skills
- adaptability
- compliance
- interpersonal skills
- team collaboration
- time management
About the role
Enzene Biosciences
Website:
enzene.com
Job details:
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 relevant scientific discipline with significant experience in biologics or biosimilar development, including leadership and regulatory exposure.
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