Manager / Executive - Formulation & Development (Softgel)

Department: Formulation & Development (F&D)

Reports to: Head Technical / Director

Experience: 510 years in F&D of soft gelatin capsules (designation will depend on experience). Experience in developing products for regulated markets is preferred.

Role Purpose

Lead development of new softgel products for pharmaceutical and nutraceutical customers, from literature survey through scale-up and technology transfer to the plant, and provide F&D documentation for regulatory filings.

Key Responsibilities

• Plan and lead development projects for new softgel products, both in-house and customer-requested, and deliver them within agreed timelines.
• Design fill formulations (solutions, suspensions, emulsions/SMEDDS) and gel shell compositions, including selection of excipients, plasticizers, opacifiers and colours.
• Carry out innovator product characterization and reverse engineering, and define the development strategy.
• Review and approve literature surveys, preformulation studies, compatibility studies and prototype trials.
• Resolve softgel-specific issues such as leakage, shell-fill migration, cross-linking, dissolution failure and physical instability.
• Plan scale-up and exhibit/validation batches, and complete technology transfer to production.
• Prepare and review PDR, MFR, BOM, development BMR/BPR, and stability protocols and reports.
• Provide pharmaceutical development data for CTD dossiers (Module 3.2.P.2) and respond to regulatory and customer technical queries.
• Review stability study data and take decisions on shelf life and formulation changes.
• Give technical support to the business development team on customer feasibility, formulation proposals and costing inputs.
• Guide and train F&D officers, allocate work and review lab records and documentation.
• Make sure the lab follows GMP, GDP and data integrity requirements.

Preferred Candidate Profile

• B.Pharm / M.Pharm (M.Pharm in Pharmaceutics preferred)
• Hands-on experience in soft gelatin capsule development is mandatory.
• Sound knowledge of ICH guidelines (Q1, Q8, Q9), GMP and development documentation
• Exposure to regulated market filings (US, EU, TGA, etc.) will be an added advantage.
• Ability to handle multiple projects and lead a small team
• Good written and oral communication skills, and proficiency in MS Office
• Strong analytical and problem-solving skills