Officer - Formulation Development (Injectables)

Why This Role Matters

Injectable formulations demand the highest level of precision, sterility assurance, and regulatory compliance. Unlike oral dosage forms, parenteral products directly enter the bloodstream, making formulation design, stability, and aseptic processing critical to patient safety.
At APDM Pharmaceuticals, the Officer / Sr. Officer – Formulation Development (Injectables) contributes to developing sterile, stable, and regulatory-compliant injectable products. This role supports innovation, process optimization, and successful scale-up at the Sakodara, Gujarat manufacturing facility.

Job Description

APDM Pharmaceuticals is seeking M.Pharm professionals with 2 to 4 years of experience in injectable formulation development. The selected candidate will be responsible for developing and optimizing sterile formulations, conducting lab trials, preparing development documentation, and supporting technology transfer.
This position requires strong knowledge of sterile product development, excipient compatibility, and regulatory expectations for parenteral dosage forms.

Key Features of the Role

• Hands-on involvement in sterile formulation development
• Exposure to aseptic processing and sterile manufacturing principles
• Participation in product lifecycle and stability studies
• Collaboration with Analytical Development and QA teams
• Experience in regulatory documentation support
• Growth opportunities within sterile R&D operations

Responsibilities

• Develop and optimize injectable formulations (liquid and lyophilized)
• Conduct pre-formulation and compatibility studies
• Perform laboratory-scale formulation trials
• Support filter compatibility and sterilization studies
• Prepare development reports and documentation as per GMP
• Coordinate with Analytical Development for method alignment
• Assist in technology transfer to sterile manufacturing
• Troubleshoot formulation-related issues
• Support preparation of regulatory submission documents
• Ensure compliance with ICH, GMP, and sterile manufacturing guidelines
• Maintain R&D records in accordance with data integrity standards

Required Qualifications

• 2 to 4 years of experience in Injectable Formulation Development
• Practical exposure to sterile product development
• Knowledge of aseptic techniques and sterilization methods
• Understanding of regulatory requirements for injectables
• Experience in stability studies and formulation optimization

Educational Requirements

• M.Pharm (Pharmaceutics) – Mandatory
• Specialization in sterile formulation or related field preferred

Experience and Skills

• Knowledge of parenteral formulation principles
• Understanding of sterilization techniques (filtration, autoclaving, etc.)
• Familiarity with lyophilization concepts (if applicable)
• Strong troubleshooting and analytical skills
• Good documentation and reporting capability
• Understanding of cleanroom and sterile area practices
• Ability to work in cross-functional teams

Salary Insights

• Performance-based increments
• Standard pharmaceutical industry benefits
• Career growth opportunities within sterile R&D
Final compensation will be aligned with sterile formulation exposure and technical competency.

Company Overview

APDM Pharmaceuticals is a growing pharmaceutical company committed to creating a healthier future through quality manufacturing and innovation. Operating from its plant in Sakodara, Gujarat, the company focuses on regulatory compliance, research excellence, and sustainable development within the Indian pharmaceutical sector.
The organization provides a structured R&D environment that supports innovation in both oral and sterile dosage forms.

FAQs

Q: Is injectable formulation experience mandatory?
A: Yes, prior experience in sterile or injectable formulation development is required.

Q: Will the role involve working in sterile areas?
A: Yes, understanding of cleanroom and aseptic practices is important.

Q: Is lyophilization experience required?
A: It is preferred but not mandatory unless specifically required for certain projects.

Q: What determines Officer vs. Senior Officer level?
A: Experience depth, independent project handling, and technical proficiency.

Application Tips

• Clearly mention types of injectables handled (liquid, lyophilized, etc.)
• Highlight sterile processing knowledge and techniques
• Quantify development projects or trials conducted
• Mention regulatory exposure and documentation experience
• Include troubleshooting examples related to stability or sterility
• Structure resume with a dedicated Sterile Formulation Projects section