Senior Executive / AM - Formulation Development (OSD)

Why This Role Matters

Formulation Development in Oral Solid Dosage (OSD) is a strategic function that determines product performance, manufacturability, and regulatory success. At advanced levels, the role moves beyond laboratory trials to include scale-up strategy, risk assessment, QbD implementation, and cross-functional leadership.
At APDM Pharmaceuticals, the Sr. Executive / Assistant Manager – Formulation Development (OSD) plays a pivotal role in leading product development initiatives, optimizing formulations, and ensuring smooth technology transfer to commercial manufacturing at the Sakodara, Gujarat facility.

Job Description

APDM Pharmaceuticals is hiring experienced M.Pharm professionals with 7 to 8 years of experience in OSD Formulation Development. The selected candidate will lead formulation projects, supervise development trials, coordinate scale-up activities, and support regulatory submissions.
This position requires strong technical command over OSD formulation techniques along with project management and team coordination capabilities.

Key Features of the Role

• Leadership role within OSD Formulation Development
• Ownership of end-to-end product development lifecycle
• Exposure to QbD-based formulation strategies
• Involvement in technology transfer and scale-up
• Regulatory documentation and dossier support exposure
• Opportunity to mentor junior formulation scientists

Responsibilities

• Lead development of tablet and capsule formulations
• Design and execute pre-formulation and optimization studies
• Implement QbD principles and risk assessment tools
• Oversee lab-scale, pilot-scale, and exhibit batch manufacturing
• Coordinate technology transfer to production department
• Troubleshoot formulation and process-related challenges
• Review and approve development documentation and reports
• Support preparation of regulatory submission documents
• Ensure compliance with ICH, GMP, and data integrity requirements
• Guide and mentor junior team members in R&D activities
• Collaborate with Analytical Development and QA teams

Required Qualifications

• 7 to 8 years of experience in OSD Formulation Development
• Strong exposure to tablets, capsules, and modified-release formulations
• Experience in scale-up and commercial batch transfer
• Understanding of regulatory filing requirements
• Proven ability to independently handle development projects

Educational Requirements

• M.Pharm (Pharmaceutics) – Mandatory
• Strong technical background in formulation sciences
• Certification or exposure to QbD (preferred)

Experience and Skills

• Expertise in wet granulation, dry granulation, direct compression
• Experience in controlled-release and immediate-release formulations
• Strong troubleshooting and problem-solving ability
• Knowledge of stability studies and product lifecycle management
• Documentation review and compliance management skills
• Leadership and team coordination capability
• Analytical mindset with strategic thinking ability

Salary Insights

• Performance-based incentives
• Standard pharmaceutical industry benefits
• Career progression into managerial R&D roles
Final compensation will depend on technical expertise, project exposure, and interview performance.

Company Overview

APDM Pharmaceuticals is a growing pharmaceutical company dedicated to creating a healthier future through quality manufacturing and innovation. Operating from its plant in Sakodara, Gujarat, the company emphasizes regulatory compliance, scientific excellence, and sustainable growth within the Indian pharmaceutical sector.
The organization provides a structured R&D environment that supports innovation, leadership development, and long-term career growth in pharmaceutical formulation sciences.

FAQs

Q: Is team handling experience required?
A: Yes, mentoring or supervising junior team members is preferred at this level.

Q: Will the role involve regulatory submission support?
A: Yes, candidates will contribute to dossier preparation and documentation review.

Q: Is QbD experience mandatory?
A: Not mandatory but highly preferred for Assistant Manager level.

Q: Does the role include scale-up exposure?
A: Yes, overseeing pilot and commercial scale-up is a key responsibility.

Application Tips

• Highlight number of products developed and transferred to production
• Mention dosage forms and release types handled
• Quantify scale-up and exhibit batch experience
• Include QbD, risk assessment, and troubleshooting exposure
• Showcase leadership or mentoring experience
• Structure resume with project-based achievements rather than routine tasks