Process Development (PD) - Generics (GM / DGM)

JOB DESCRIPTION PROCESS DEVELOPMENT (PD) GENERICS

Position: General Manager / Deputy General Manager - Process Development (Generics)

ROLE SUMMARY

We are looking for an experienced Process Development professional to lead Generic API development projects from route selection through process optimization, scale-up, and technology transfer to manufacturing.

The incumbent will lead a team of approximately 1020 members and will be responsible for developing safe, robust, scalable, reproducible, and cost-effective processes while ensuring project timelines, quality, regulatory, EHS, and business objectives are met.

KEY RESPONSIBILITIES

Process Development & Project Management

• Lead and supervise multiple Generic API Process Development projects with a team of 1020 members.
• Plan project activities, timelines, resources, experiments, and priorities to ensure timely project execution.
• Monitor day-to-day laboratory activities and conduct regular technical reviews with team members.
• Provide technical guidance, troubleshoot challenges, and ensure successful project delivery.
• Prepare project progress reports and communicate development status, risks, and requirements to senior management.

Route Selection & Process Development

• Conduct route scouting and detailed evaluation of patents, literature, and available technical information for selection of suitable synthetic routes.
• Evaluate IP implications of published patents/literature and develop alternate/non-infringing routes where required.
• Develop safe, robust, scalable, reproducible, and commercially viable processes for Generic APIs.
• Optimize reaction parameters, work-up, isolation, purification, crystallization, and other process parameters to achieve desired quality, yield, productivity, and cost targets.
• Identify and control process-related impurities and improve overall process robustness and manufacturability.

Analytical & Quality Coordination

• Review and interpret analytical data generated during process development and scale-up.
• Coordinate with Analytical Development, QC, QA, and other CFTs for impurity evaluation, specifications, STPs, and process-related quality requirements.
• Ensure appropriate analytical support for process development, optimization, investigations, and technology transfer.

Scale-up & Technology Transfer

• Lead scale-up activities from laboratory to pilot / manufacturing scale.
• Identify and mitigate scale-up and process risks.
• Prepare and review process development reports, process descriptions, technology transfer documents, and other technical documentation.
• Coordinate with Manufacturing / Production, QA, QC, Engineering, RA, Supply Chain, and other CFTs for successful technology transfer.
• Provide technical support during pilot and commercial batches and resolve process-related manufacturing issues.

Regulatory & Compliance

• Prepare and provide required technical documents and responses to RA / QA for regulatory submissions, audits, inspections, and regulatory queries.
• Support customer and regulatory audits and ensure development activities are inspection-ready.
• Ensure all laboratory activities and documentation comply with GLP, GMP, SOPs, Data Integrity, and applicable statutory requirements.

Cross-Functional Coordination

• Work closely with Manufacturing, Analytical Development, QC, QA, Regulatory Affairs, Engineering, EHS, Purchase, Sourcing, and Supply Chain teams.
• Coordinate with Purchase / Sourcing to ensure timely availability of raw materials, starting materials, solvents, reagents, and other development requirements.

People Leadership

• Lead, mentor, and develop a team of 1020 scientists / research professionals.
• Allocate projects and responsibilities based on technical capability and business priorities.
• Build technical competencies, encourage scientific problem-solving, and promote a culture of quality, safety, innovation, and accountability.

EHS & Safety

• Ensure strict adherence to EHS requirements in all laboratory and scale-up activities.
• Assess chemical and process hazards and implement appropriate safety controls.
• Promote a strong safety culture and immediately escalate unsafe conditions or incidents.

EDUCATIONAL QUALIFICATION

• M.Sc. in Chemistry
• Preferred: Ph.D. in Chemistry / Pharmaceutical Sciences / related discipline.

EXPERIENCE

• Strong experience in Generic API / Pharmaceutical Process Development.
• Experience in route selection, process optimization, scale-up, and technology transfer.
• Experience in managing multiple development projects and leading technical teams.
• Experience in patent / literature evaluation and alternate route development is highly preferred.
• Exposure to commercial manufacturing, regulatory requirements, and CMC activities will be an added advantage.