Formulation & Development (F&D)

Level: Department Head / Senior Management

Job Purpose The Head – Formulation & Development will be responsible for leading the formulation development function for pharmaceutical products from product concept through laboratory development, scale-up, technology transfer, validation, and commercialization.

The role will ensure development of robust, stable, cost-effective, scalable, and regulatory-compliant formulations while coordinating with Analytical Development, Quality Assurance, Quality Control, Regulatory Affairs, Production, Purchase, Packaging Development, and external manufacturing partners.

Key Responsibilities

1. Formulation Development

• Lead development of new pharmaceutical formulations including tablets, capsules, oral liquids, topical preparations, and other dosage forms handled by the company.
• Design formulation development strategies based on API characteristics, target product profile, therapeutic requirements, regulatory requirements, and commercial objectives.
• Conduct and supervise pre-formulation studies, excipient compatibility studies, formulation trials, optimization studies, and stability studies.
• Select suitable APIs, excipients, manufacturing processes, and packaging systems.
• Develop robust and reproducible manufacturing processes suitable for commercial-scale production.

2. New Product Development

• Evaluate new product opportunities from technical and development perspectives.
• Prepare development plans, timelines, technical feasibility reports, and development priorities.
• Coordinate development activities for new molecules, line extensions, new strengths, and new dosage forms.
• Support management in technical evaluation and prioritization of the product pipeline.

3. Scale-Up & Technology

• TransferLead laboratory-scale, pilot-scale, exhibit/validation batch, and commercial-scale development activities.
• Prepare and review technology transfer documents.
• Transfer developed formulations and manufacturing processes to internal or third-party manufacturing plants.
• Coordinate with Production, QA, QC, Engineering, and manufacturing sites during scale-up and commercialization.
• Troubleshoot formulation and process-related issues during scale-up and commercial manufacturing.

4. Product Optimization & Troubleshooting

• Investigate formulation, manufacturing, stability, dissolution, assay, impurity, physical appearance, and packaging-related issues.
• Recommend corrective and preventive measures for product/process failures.
• Work on product improvement, cost optimization, yield improvement, and process simplification.
• Support investigation of deviations, OOS/OOT results, market complaints, and recurring production issues where formulation input is required.

5. Stability & Product Performance

• Design appropriate stability study protocols in coordination with QA/QC.
• Review accelerated, intermediate, and long-term stability data.
• Evaluate product shelf-life, packaging suitability, and formulation robustness.
• Initiate reformulation or process optimization wherever stability concerns are identified.

6. Documentation

• Ensure preparation, review, and maintenance of:
• Product Development Reports
• Master Formula Records
• Manufacturing Process Instructions
• Batch Manufacturing Records
• Technology Transfer Documents
• Development Protocols
• Trial Reports
• Scale-Up Reports
• Validation-support documents
• Stability protocols/reports
• Technical specifications
• Development history and supporting records
• Ensure proper documentation and traceability of all developmental activities.

7. Regulatory Support

• Provide formulation-development inputs for regulatory submissions.
• Support preparation and review of pharmaceutical development sections of dossiers.
• Provide technical data required for product registrations, renewals, variations, and regulatory queries.
• Ensure developed formulations meet applicable Indian and international regulatory requirements wherever relevant.

8. Vendor & Third-Party Coordination

• Technically evaluate API, excipient, packaging-material, and manufacturing vendors.
• Coordinate development trials with third-party manufacturers and contract research/development organizations.
• Review technical capabilities of manufacturing plants before product transfer.
• Participate in discussions with vendors for alternate sources and cost optimization.

9. Cross-Functional CoordinationWork closely with:

• Analytical Development
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Production
• Purchase / Supply Chain
• Packaging Development
• Engineering
• Commercial / Marketing
• External manufacturing partners

Ensure timely movement of products from concept to commercial launch.

10. Team Management

• Lead and develop the Formulation Development team.
• Allocate projects and responsibilities according to business priorities.
• Review formulation trials, development data, and project progress.
• Train team members in formulation science, documentation, troubleshooting, GMP, and development procedures.
• Establish KPIs and periodically review team performance.
• Build technical capability and succession planning within the department.

11. Compliance & Quality

• Ensure all development activities comply with applicable GMP, GLP, GDP, internal SOPs, and regulatory requirements.
• Ensure proper data integrity and documentation practices.
• Support internal, customer, regulatory, and third-party audits related to development activities.
• Implement CAPA arising from audits or development-related observations.

Candidate ProfileEducational QualificationPreferred qualification:

• M.Pharm – Pharmaceutics / Industrial Pharmacy
• Ph.D. in Pharmaceutics / Pharmaceutical Sciences will be an added advantage.
• Experience Preferably 5-7 years of pharmaceutical formulation-development experience.
• Minimum 5 years in a managerial / team leadership position preferred.
• Strong experience in formulation development, scale-up, technology transfer, troubleshooting, stability assessment, and commercialization.

Experience requirements can be adjusted depending on the size and complexity of the organization.

Technical Knowledge Required

The candidate should have strong knowledge of:

• Pre-formulation studies
• Formulation design and optimization
• Tablets and capsules
• Oral liquids / suspensions / syrups
• Topical / semi-solid formulations, where applicable
• Granulation, compression, coating, encapsulation, and other manufacturing processes
• Scale-up and process optimization
• Technology transfer
• Stability studies
• Excipient functionality
• API–excipient compatibility
• Dissolution and drug-release concepts
• Packaging compatibility
• GMP / GLP / GDP
• ICH guidelines
• Pharmaceutical documentation
• Quality by Design (QbD)
• Risk assessment
• Process validation
• Regulatory requirements
• Investigation and troubleshooting
• Key Skills & CompetenciesStrong formulation-development expertise
• Scientific and analytical thinking
• Problem-solving ability
• Leadership and team-management skills
• Project-management capability
• Decision-making ability
• Strong documentation and review skills
• Commercial and cost-conscious approach
• Cross-functional coordination
• Vendor and manufacturing-partner management
• Good communication and presentation skills
• Ability to manage multiple development projects simultaneously

Key Performance Indicators – KPIsPerformance may be evaluated on:

• Number of new products successfully developed
• Development projects completed within agreed timelines
• First-time-right scale-up / technology transfer
• Successful commercial launches
• Product stability and formulation robustness
• Reduction in development failures and repeat trials
• Resolution time for technical/product issues
• Development cost control
• Product cost optimization
• Documentation compliance
• Regulatory query response support
• Team productivity and capability development

Preferred Candidate: The preferred candidate should be a technically strong pharmaceutical formulation professional with hands-on experience from development to commercialization, capable of independently managing formulation projects, troubleshooting technical issues, coordinating with manufacturing plants, and leading an F&D team.

The candidate should combine scientific formulation expertise with practical manufacturing knowledge and commercial understanding to develop quality products that are stable, scalable, compliant, and commercially viable.