Executive / Sr. Executive - (Oral Solid Oncology)

Umedica Labs; Navi Mumbai; On-site; INR 500,000 - 800,000; Full time

Job summary

Umedica Labs in Navi Mumbai is seeking a skilled professional for formulation development of oral solid dosage forms for oncology products. The role involves executing formulation activities, conducting pre-formulation studies, and ensuring compliance with regulatory standards.

The ideal candidate will hold an M.Pharm or B.Pharm degree with hands-on experience in formulation development processes. A thorough understanding of quality by design (QbD) concepts and regulatory requirements is essential.

Qualifications

• Hands-on experience in formulation development of oral solid dosage forms.
• Understanding of regulatory requirements for generic product development.
• Experience in handling formulation development equipment.

Responsibilities

• Execute formulation development activities for oncology products.
• Conduct laboratory scale trials and scale-up activities.
• Prepare and maintain development documents as per protocols.

Skills

Formulation development of oral solid dosage forms

Knowledge of QbD concepts

Risk assessment

Pharmaceutical development approaches

Regulatory requirements for generic product development

Education

M.Pharm / B.Pharm (Pharmaceutics or relevant specialization)

Tools

Blender

Granulator

Compression machine

Capsule filling machine

Job description

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, Good 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.