Delivery Lead - Formulation R & D

Job Title: Delivery Lead Formulation R&D
Company: Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL)
Location: Gagillapur, Hyderabad.

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 1015 years and Ph.D with 612 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
• New 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 removed]

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