JOB DESCRIPTION

Manager / Executive – Formulation & Development (Softgel)

Company: Renown Pharmaceuticals Pvt. Ltd. (Renown Group)

Department: Formulation & Development (F&D;)

Location: Vadodara, Gujarat

Reports to: Head – Technical / Director

Experience: 5–10 years in F&D; of soft gelatin capsules (designation will depend on experience). Experience in developing products for regulated markets is preferred.

Employment Type: Full Time, Permanent

About Us

Renown Pharmaceuticals is a contract manufacturer of soft gelatin capsules exporting to 30+ countries. We operate two dedicated facilities: a pharmaceutical facility designed for highly regulated markets, and a nutraceutical facility for food supplements. We are targeting US OTC, PIC/S and RoW markets.

Role Purpose

Lead development of current 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

Key Skills: Softgel formulation, Formulation & Development, Technology Transfer, Scale-up, PDR, Literature Survey, Stability Studies, CTD Module 3, ICH Guidelines, Drug Development

Pay: ₹50,000.00 - ₹70,000.00 per month

Benefits:

- Health insurance
- Leave encashment
- Provident Fund

Work Location: In person

📌 Manager Formulation & Development(F&D) (Ranu)
🏢 RENOWN PHARMACEUTICALS
📍 Ranu