Manager – Formulation Development (Non-Orals)

About the role

This position is for a Manager in Formulation Development for non-oral dosage forms within Sun Pharma’s R&D and Regulatory Affairs setup in Vadodara. The role focuses on injectable product development, including liquid, lyophilized, and complex injectable products, with ownership of development, documentation, technical support, and cross-functional coordination.

The organization emphasizes continuous growth, accountability, and teamwork, with a culture built around progressing steadily, taking initiative, and collaborating effectively.

What you will do

• Lead assigned development projects end to end and work closely with other teams to keep submissions and approvals on schedule as per the agreed plan.
• Contribute technical inputs throughout the development cycle to support timely filing activities.
• Carry out literature review and patent-landscape assessment for assigned projects and identify the quickest viable route toward successful submission.
• Perform pre-formulation work and formulation trials using a QbD-based approach to create a strong and reliable formulation.
• Prepare batches for stability testing and analytical method validation.
• Support scale-up and exhibit-batch execution at the plant.
• Review test request reports for raw materials such as APIs and excipients, as well as finished drug products.
• Document manufacturing operations in the laboratory notebook accurately and in detail.
• Draft development study protocols and execute the studies accordingly.
• Prepare and check stability protocols for charging stability batches as specified.
• Compile and review stability documentation and development study reports using available COAs.
• Develop and validate technology transfer documents such as Sheet II, MF, risk assessment based on CPP/CQA, and FMEA.
• Prepare Pre-IND, IND, and NDA packages for regulatory communication.
• Define in-process and finished-product specifications with proper scientific justification.
• Prepare development reports with supporting data for regulatory filings.
• Draft and review SOPs related to laboratory equipment and instruments.
• Participate in equipment and instrument qualification activities for new procurements and review qualification documents.
• Maintain compliance with the internal quality system during all work activities.
• Respond to FDA queries within required timelines.
• Coordinate project and product activities with teams such as ADD, RA, CQA, and Plant.
• Drive projects with internal and external stakeholders to meet milestones and deadlines.
• Suggest practical and innovative ways to simplify development and strengthen product robustness.
• Support project transfer and troubleshoot issues using technical solutions so the product can be manufactured successfully after approval.

Requirements

• 8 to 12 years of relevant experience in R&D product development.
• Hands-on experience with injectable product development, including liquid, lyophilized, and complex injectable dosage forms.
• Strong execution capability and the ability to manage timelines across functions.
• Experience with literature review, patent evaluation, QbD, stability studies, and analytical method validation.
• Knowledge of regulatory documentation and filing support such as Pre-IND, IND, and NDA packages.
• Ability to prepare technical and scientific documentation, including protocols, reports, specifications, and technology transfer papers.
• Experience in scale-up, exhibit batches, and plant-level coordination.
• Ability to work with cross-functional teams and external stakeholders.
• Familiarity with equipment qualification, SOP preparation, and quality-system compliance.
• Capability to provide practical technical solutions for troubleshooting and process transfer.

Additional information

Job grade: G11A/G10

Business unit: R&D1 Regulatory Affairs

Location: Vadodara, India

Travel estimate: NA

Qualification: M.Pharm

Experience range: 8 to 12 years of relevant experience

Disclaimer

This description reflects the general nature of the role and the level of work expected. It is not a complete list of every duty, responsibility, or qualification, and the employer may update responsibilities or assign comparable duties as needed.