Urgent Hiring |Formulation Development Head | Injectable & Ophthalmic

Dear Candidates,

Greetings!

Please find below the company profile and JD :

• Job Description Manager, Formulation & Development (Injectables & Ophthalmics)
• Position: Manager Formulation & Development (Injectables & Ophthalmics)
• Department: Research & Development (R&D)
• Industry: Pharmaceutical Contract Manufacturing (CDMO/CMO)
• Location: Dehradun Selaqui
• Experience: 10–20 Years
• Qualification: M.Pharm / B.Pharm (Pharmaceutics Preferred)

Job Summary

We are seeking an experienced Manager – Formulation & Development to lead the development of sterile injectable and ophthalmic products for domestic and regulated markets. The role involves managing formulation development activities, technology transfer, team leadership, client interactions, and ensuring compliance with regulatory requirements while supporting business growth in a contract manufacturing environment.

Key Responsibilities

Formulation & Product Development

• Lead formulation development of sterile injectables and ophthalmic products from concept to commercialization.
• Design and oversee pre-formulation studies, formulation optimization, and process development activities.
• Develop robust, scalable, and cost-effective formulations in line with customer and regulatory requirements.
• Drive Quality by Design (QbD) and risk assessment approaches during product development.

Technology Transfer & Commercialization

• Lead technology transfer activities from R&D to manufacturing.
• Provide technical guidance during exhibit, validation, and commercial batches.
• Troubleshoot formulation and process-related challenges during scale-up and manufacturing.

Regulatory & Compliance

• Ensure compliance with cGMP, ICH, WHO, EU GMP, and other applicable regulatory requirements.
• Review development reports, protocols, specifications, and regulatory documentation.
• Support dossier preparation and regulatory submissions for domestic and international markets.

Project & Client Management

• Act as the technical lead for customer projects in a CDMO/CMO environment.
• Participate in client meetings, technical discussions, audits, and project reviews.
• Manage project timelines and ensure timely delivery of development milestones.

Team Leadership

• Lead and mentor a team of formulation scientists and research associates.
• Allocate resources, monitor project progress, and ensure achievement of departmental objectives.
• Drive continuous improvement initiatives and foster innovation within the R&D team.

Desired Skills

• Formulation Development of Sterile Injectables & Ophthalmics
• Liquid Injectables
• Ophthalmic Solutions, Suspensions & Ointments
• Technology Transfer & Scale-Up
• QbD and Risk Assessment
• Stability Studies
• Regulatory Documentation
• cGMP, ICH, EU GMP Compliance
• Project Management
• Team Leadership & Stakeholder Management

Preferred Industry Experience

• Pharmaceutical Contract Manufacturing (CDMO/CMO)
• Sterile Manufacturing Facilities
• Injectables Manufacturing
• Ophthalmic Manufacturing
• Regulated Market Exposure ( EU, ROW)

Thanks & Regards

HR Department