Sun Pharma: Executive – Formulation R&D
About the Company
This role is ideal for candidates with a solid background in Formulation R&D, particularly in injectable product development. If you are detail-oriented, possess strong documentation skills, and can effectively collaborate with cross-functional teams, we encourage you to apply and be part of Sun Pharmaceutical Industries Ltd.
Position Name:
Executive – Formulation R&D
Organization:
Sun Pharma
Qualification:
- B.Pharm, M.Pharm
- M.Sc, B.Sc
- Ph.D
Experience:
- 1 to 2 Years
Salary:
- Not disclosed
Location:
- Gujarat
Role and Responsibilities
| Responsibility | Description |
|---|---|
| Formulation Development | Develop injectable products, including novel drug delivery systems, lyophilized products, and solution products. Conduct literature searches relevant to project requirements and regulatory guidance. |
| Procurement and Documentation | Procure raw materials (API/excipients), packaging materials, and reference products in consultation with the packaging/purchase department. Prepare request applications for testing/analysis licenses for new/reference products. |
| Experimental Design and Data Management | Design and conduct pre-formulation and formulation development experiments using a QbD approach. Record details of drug product manufacturing experiments in Lab Notebooks. |
| Analysis and Protocol Preparation | Prepare TR/IOM for API/excipients/product sample analysis. Develop product development/stability study protocols and reports. Prepare SOPs for related laboratory equipment/instruments and maintain critical data records for regulatory audits. |
| Technology Transfer and Risk Assessment | Prepare documents for Technology Transfer, including Master Formula, Risk Assessment based on CPP & CQA, FMEA, and SDS. Collaborate with cross-functional teams for lab management, instrument handling, and common group activities. |
| Support and Coordination | Support cross-functional activities at the plant for scale-up, exhibit batches, commercial batches, and new assignments. Prepare Product Development Reports (PDR), risk assessment reports, and compile project issues. |
| Quality Compliance | Comply with internal quality systems while performing all activities. |
Qualifications and Experience
- Education: Background in Formulation R&D, preferably with experience in injectable product development.
- Experience: Proven experience in developing products within novel drug delivery systems, lyophilized products, or solution products.
- Skills:
- Proficiency in literature searches and understanding of regulatory guidance.
- Ability to design and conduct formulation experiments using a QbD approach.
- Strong documentation skills, including the preparation of TR/IOM, SOPs, and regulatory reports.
- Experience in technology transfer and risk assessment methodologies (CPP & CQA, FMEA).
- Effective collaboration and coordination with cross-functional teams.
- Strong adherence to quality compliance systems.
Additional Information
- Location: This role is based at the Tandalja R&D facility.
- Company Overview: Sun Pharmaceutical Industries Ltd is a global leader in the pharmaceutical industry, known for its innovation and commitment to quality. The company offers a dynamic and collaborative working environment, with opportunities for professional growth and development.