? Job Title: Delivery Lead – Formulation R&D;

? Company: Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL)

? Location: Gagillapur, Hyderabad.

? Apply at: [email protected] ? +91 6302 451 459

About Us

Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D; organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs

Position Summary

Delivery Lead – Formulation R&D; will be responsible for leading formulation development activities across Topicals, Nasal Sprays and Injectables. The role ensures robust product development, successful scale-up, technology transfer from R&D; to manufacturing, and regulatory compliance.

Key Responsibilities

Formulation Development Responsibilities

- Develop and optimize formulations for tablets and capsules (IR/MR), creams, ointments, gels, nasal sprays and injectables (liquid/lyophilized)
- Conduct pre-formulation studies, compatibility studies, and excipient selection
- Design and execute formulation trials and optimization strategies
- Perform scale-up activities and exhibit batch execution
- Handle technology transfer (TT) from R&D; to production
- Prepare and review MFR, BMR, protocols, reports, and development documents
- Troubleshoot formulation and process-related issues

Regulatory & Compliance

- Ensure compliance with ICH guidelines, cGMP, USFDA, EU regulations
- Support CTD/ANDA filing and documentation requirements




- Maintain data integrity (ALCOA+) and documentation compliance
- Participate in internal audits and regulatory inspections

Required Skills & Qualifications

- M. Pharm / Ph.D in Pharmaceutics
- M. Pharm with 10–15 years and Ph.D with 6–12 years of experience in Formulation R&D; (Pharma industry)
- Minimum 3 ANDA filings or experience in complex generics is mandatory
- Hands-on experience in formulation developments of various dosage forms applying QbD principles
- Strong knowledge of novel and emerging formulation techniques, process development
- Experience in technology transfer and scale-up activities
- Exposure to regulated markets (USFDA, EU, WHO)
- Good documentation, analytical, and communication skills

Key Competencies

- Strong technical expertise in formulation development
- Recent project ideation and strategic planning
- Analytical thinking & problem-solving skills
- Leadership & team handling capability
- Cross-functional coordination
- Quality & compliance mindset

Why Join MPDRPL?

- Work on diverse dosage forms (OSD, Topicals, Nasal, Injectables)
- Exposure to AI/ML driven formulation and process development and optimization
- Exposure to global regulatory projects and filings
- Innovation-driven R&D; environment
- Career growth and advancement opportunities

Application Process To apply, submit your updated CV and a cover letter highlighting your relevant experience to:

? [email protected]

MPDRPL is an equal opportunity employer committed to a diverse and inclusive workplace.

📌 Delivery Lead - Formulation R&D (Gandi Maisamma)
🏢 Morepen Proprietary Drug Research
📍 Gandi Maisamma