Are you a passionate M.Pharm professional with 1-5 years of experience in formulation development? Sun Pharmaceutical Industries Ltd, a global leader in specialty generics, is hiring for the role of Executive – FRD Non Orals in their R&D facility at Tandalja, Baroda. This is an exciting opportunity to work on innovative non-oral dosage forms like microspheres, implants, and in-situ gels, contributing to cutting-edge pharmaceutical advancements using Quality by Design (QbD) principles.
At Sun Pharma, we are committed to helping you “Create your own sunshine” by providing a supportive environment where you can grow professionally, take charge of your career, and thrive collaboratively. Join a team that values continuous improvement, self-drive, and teamwork – become ‘Better every day’ in a culture that fosters innovation and impact.
Roles and Responsibilities
As an Executive in Formulation Research & Development (FRD) for Non-Orals, you will play a key role in developing complex dosage forms. Key responsibilities include:
- Designing and conducting experiments for preformulation and formulation optimization of microspheres and long-acting complex non-oral dosage forms (e.g., implants, in-situ gels) based on QbD approach.
- Executing experiments as per Design of Experiments (DoE).
- Performing literature searches, preparing summary reports, and reviews for ANDA projects.
- Preparing product development study protocols and reports in compliance with regulatory requirements.
- Entering experimental details, observations, and test requests in eLNB/METIS software.
- Compiling and interpreting experimental trials and stability study results using MINITAB software.
- Preparing Technology Transfer documents, including Master Formula (MF) and Risk Assessments based on CPP & CQA.
- Preparing justifications for import materials, Form 29 applications, and Common Pharmaceutical Documents for DCGI submissions.
- Executing scale-up/exhibit batches at the plant and preparing scale-up summary reports.
- Preparing stability protocols as per regulatory requirements.
- Preparing Product Development Reports and Risk Assessment reports for elemental impurities, residual solvents, and extractables for regulatory submissions.
- Preparing pre-ANDA meeting packages, scientific justifications, and reports for various regulatory agencies.
- Preparing SOPs for laboratory equipment/instruments.
- Participating in equipment/instrument qualification activities and preparing/reviewing qualification documents.
- Ensuring compliance with internal quality systems in all activities.
- Coordinating with cross-functional departments like Analytical Development (ADD), Regulatory Affairs (RA), CQA, and Plant for project-related activities.
Required Qualifications and Experience
To succeed in this role, candidates should meet the following criteria:
- Educational Qualification: M.Pharm (Pharmaceutics or equivalent specialization preferred).
- Experience: 1-5 years in Formulation R&D, specifically with non-oral dosage forms.
- Strong knowledge of QbD, DoE, regulatory guidelines (ANDA, DCGI), and tools like MINITAB, eLNB/METIS.
- Excellent documentation skills and ability to work in a cross-functional team.
Salary, Benefits, and How to Apply
Sun Pharma offers a competitive compensation package for this Executive role. The expected salary range is INR 5,00,000 to 8,00,000 per annum, depending on experience, qualifications, and performance during the selection process.
Employees at Sun Pharma enjoy comprehensive benefits, including health insurance, professional development opportunities, performance-linked incentives, and a supportive work culture focused on growth and well-being. Your success and personal development are prioritized, with ample opportunities to collaborate and make a meaningful impact in the pharmaceutical industry.
How to Apply: Interested candidates should visit the official Sun Pharma careers portal at sunpharma.com/careers or send their updated resume to the HR team as per the company’s recruitment process. Mention “Executive – FRD Non Orals, Baroda” in the subject line. Only shortlisted candidates will be contacted.
