Role & responsibilities

- Execute formulation development activities for oncology and high-potent (HPAPI) products, including oral liquid dosage forms (solutions, suspensions) and sterile injectable formulations.
- Perform pre-formulation studies, excipient compatibility studies, solubility assessments, and formulation optimization to achieve desired product performance and stability.
- Design and execute laboratory trials, prepare developmental batches, and support process optimization, scale-up, and technology transfer to manufacturing sites.
- Develop robust formulations considering critical quality attributes (CQAs), critical process parameters (CPPs), and Quality by Design (QbD) principles.
- Prepare and maintain development documents including laboratory notebooks, batch manufacturing records (BMRs), development protocols, reports, specifications, and technical documents in compliance with GDP requirements.
- Evaluate formulation characteristics, stability data, analytical results, and process performance data to support product development and regulatory submissions.
- Support troubleshooting of formulation, process, scale-up, and manufacturing-related challenges.
- Coordinate effectively with Analytical R&D;, Quality Assurance (QA), Quality Control (QC), Production, Engineering, and Regulatory Affairs teams to ensure timely project execution.
- Ensure strict compliance with cGMP, ICH guidelines, data integrity requirements, EHS practices, and oncology/HPAPI handling procedures.
- Maintain laboratory equipment qualification status, calibration records, laboratory housekeeping, and safe handling practices within oncology development facilities.

Educational Qualification

- M.Pharm / B.Pharm (Pharmaceutics) or relevant pharmaceutical qualification from a recognized university.





Technical Competencies

- Hands-on experience in oncology formulation development, including oral liquid dosage forms and/or sterile injectable products.
- Robust understanding of formulation principles, excipient selection, compatibility studies, formulation optimization, and process development.
- Knowledge of sterile formulation development concepts, aseptic processing requirements, and injectable product development will be an added advantage.
- Practical exposure to QbD approaches, risk assessment, stability studies, analytical data interpretation, and pharmaceutical development lifecycle.
- Experience in handling HPAPI products, containment practices, and oncology safety requirements.
- Understanding of ICH guidelines, cGMP, regulatory requirements, and development expectations for regulated markets such as US, EU, and other international markets.
- Exposure to scale-up activities, technology transfer, process validation support, and commercial manufacturing considerations.

Preferred Candidate Profile

- 26 years of experience in Pharmaceutical Formulation R&D; with exposure to oncology formulations, oral liquid products, and/or sterile injectable development.
- Experience in development of HPAPI/oncology products for regulated markets (USFDA, EU-GMP, MHRA, etc.) will be highly preferred.
- Hands-on exposure across the product development lifecycle including laboratory development, optimization, exhibit/registration batches, scale-up, technology transfer, and manufacturing support.
- Knowledge of regulatory documentation requirements such as development reports, pharmaceutical development sections, and technical dossiers will be an added advantage.

Interested candidates can apply or share their resume on vaishnavi.k@umedicalabscom

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