Assistant General Manager - Formulation Development

Job Description

Role Summary

The AGM Formulation Development & Manufacturing will be responsible for leading and managing formulation development activities for oncology and generic pharmaceutical products across solid oral and liquid oral dosage forms. The role involves strategic oversight of product development, manufacturing coordination, scale-up activities, technology transfer, regulatory support, and cross-functional leadership.

The incumbent will drive innovation, ensure regulatory compliance, and support successful execution of development programs aligned with client and organizational objectives.

Key Responsibilities

Formulation Development

• Lead formulation development activities for:
• Oncology products
• Generic pharmaceutical products
• Solid oral dosage forms
• Liquid oral dosage forms
• Design and optimize formulations based on QbD principles and regulatory expectations.
• Execute pre-formulation studies, prototype development, optimization, and stability studies.
• Review and approve formulation development reports, protocols, and technical documentation.

Manufacturing & Technology Transfer

• Oversee exhibit, pilot, scale-up, and commercial batch manufacturing activities.
• Coordinate technology transfer activities from R&D to manufacturing.
• Troubleshoot manufacturing and process-related issues.
• Ensure smooth execution of process validation and scale-up activities.

Regulatory & Compliance

• Support regulatory submissions for global markets including USFDA, EMA, and other regulated markets.
• Review CMC sections, development reports, and product dossiers.
• Ensure compliance with cGMP, data integrity, and regulatory requirements.

Project & Client Management

• Interact with clients for technical discussions, project updates, and development strategies.
• Manage project timelines, deliverables, and resource allocation.
• Participate in client audits and regulatory inspections.

Leadership & Team Management

• Lead and mentor formulation scientists and technical teams.
• Drive scientific excellence and foster a collaborative work culture.
• Support recruitment, training, and performance development of team members.

Cross-Functional Coordination

• Work closely with:
• Analytical Development
• Quality Assurance
• Regulatory Affairs
• Production
• Procurement
• Business Development teams

Desired Candidate Profile

Education

• M.Pharm / Ph.D. in Pharmaceutics or related pharmaceutical sciences discipline.

Experience

• 1520 years of relevant experience in pharmaceutical formulation development and manufacturing.
• Strong exposure to oncology product development.
• Experience in handling solid oral and liquid oral dosage forms.
• Prior experience in regulated market projects (USFDA/EMA) preferred.
• Experience in CRO/CDMO/pharmaceutical R&D environment desirable.

More Info

Education