Role & responsibilities

- Execute formulation development activities for oral solid dosage forms such as tablets and capsules for oncology products.
- Perform pre-formulation studies, excipient compatibility studies, and evaluate critical material attributes.
- Develop and optimize formulations using suitable manufacturing processes including direct compression, dry granulation, and wet granulation techniques.
- Conduct laboratory scale trials, optimization batches, and scale-up activities as per approved development plans.
- Prepare and maintain development documents including laboratory notebooks, batch manufacturing records (BMRs), protocols, reports, and technical documents.
- Evaluate physical and chemical characteristics of formulations including blend properties, tablet/capsule parameters, dissolution profiles, and stability data.
- Perform literature review, patent search analysis, and support product development strategies.
- Coordinate with Analytical Development, Quality Assurance, Production, and Regulatory Affairs teams during product development and technology transfer activities.
- Support exhibit batch manufacturing, process validation activities, and successful transfer of products to manufacturing sites.
- Ensure adherence to cGMP,



Valuable Documentation Practices (GDP), data integrity principles, and EHS guidelines, especially related to handling of oncology products.
- Participate in investigations, troubleshooting, and implementation of corrective and preventive actions (CAPA) related to formulation development activities.
- Maintain proper housekeeping and safety practices within the R&D; laboratory and oncology containment areas.

Required Qualifications & Skills

- M.Pharm / B.Pharm (Pharmaceutics or relevant specialization) from a recognized university.
- Hands-on experience in formulation development of oral solid dosage forms.
- Knowledge of QbD concepts, risk assessment, DoE, and pharmaceutical development approaches.
- Understanding of regulatory requirements for generic product development for regulated markets (USFDA, EU, etc.).
- Experience in handling formulation development equipment such as blender, granulator, compression machine, capsule filling machine, and related laboratory instruments.
- Knowledge of dissolution profile comparison, stability studies, and product optimization.

Interested candidates can apply or share their resume on [email protected]

📌 Executive / Sr. Executive - (Oral Solid Oncology) (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai