GM / DGM / AGM - Analytical Development (ADL) - API

Job Overview

We are seeking a highly seasoned, strategic, and technically sound leader for the role of GM / DGM / AGM - Analytical Development (API). This role demands an expert with comprehensive knowledge of analytical chemistry, current global regulatory frameworks, and advanced laboratory systems. The successful candidate will spearhead multiple complex API projects, manage a robust team of scientists, ensure flawless tech transfer to Quality Control, and maintain top-tier GLP/GMP compliance in the laboratory.

Key Responsibilities & DutiesProject Management & Execution

• Strategic Planning: Oversee the planning, resource allocation, and timely execution of multiple complex API analytical projects.
• Review Meetings: Lead and actively participate in cross-functional project milestone review meetings.
• Team Governance: Manage, mentor, and build the technical capabilities of a large team of scientists (ranging from 15 to 30+ members).

Documentation, Quality & Compliance (eQAMS)

• Technical Review: Authorize, review, and approve critical technical documents including Protocols, Reports, Specifications, Standard Testing Procedures (STPs), and Method Validation data.
• QMS Ownership: Drive the initiation, tracking, and closure of Quality Management System documents (Deviations, Change Controls, OOS, OOT) using automated eQAMS platforms.
• Lab Standards: Ensure absolute implementation of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) within the ADL environment.
• Training Initiatives: Champion and drive continuous employee participation in cGMP, Environment Health & Safety (EHS), and specific technical training programs.

Cross-Functional Tech Transfer & Collaboration

• Method Transfer: Coordinate directly with the Plant Quality Control (QC) teams for seamless analytical method validation and technology transfer activities.
• Matrix Collaboration: Act as the primary technical bridge between ADL and crucial departments including Regulatory Affairs (RA), Quality Assurance (QA), R&D Synthesis, and Commercial Manufacturing.

Core Competencies & Technical Skills

• Chromatographic & Analytical Expertise: Advanced, authoritative knowledge of modern chromatographic techniques (HPLC, GC, LC-MS) and classical wet chemistry methodologies.
• Regulatory Compliance: Deep, practical understanding of current global regulatory guidelines (ICH, USFDA, EMA, PMDA) regarding API impurities, characterization, and stability metrics.
• Leadership Scale: Proven track record of handling a minimum of 5 to multiple parallel fast-track API projects while handling multi-tier teams.

Candidate Profile Requirements

• Education: Post Graduation / Masters Degree in Organic Chemistry, Analytical Chemistry, or Pharmaceutical Chemistry.
• Experience Range: 20 to 28 Years of progressive experience in an API Analytical Development Laboratory (ADL), with substantial years spent in a senior managerial capacity.
• Key Attributes: Strong adherence to corporate compliance, stellar communication, conflict resolution skills, and executive decision-making capabilities.