Role and Responsibilities:
- 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.
