Role & responsibilities

- Develop and optimize oral solid oncology formulations including tablets and capsules.

- Conduct pre-formulation studies,excipient compatibility studies, and formulation trials.

- Execute laboratory, pilot, exhibit and scale-up batches, ensuring successful technology transfer to manufacturing.

- Support development of cytotoxic/high-potency oncology products in compliance with safety and containment requirements.

- Prepare and review formulation development reports, stability protocols, and regulatory documentation.

- Collaborate with Analytical R&D;, Regulatory Affairs, Production, QA, and other cross-functional teams to meet project timelines.

- Investigate and resolve formulation and process-related challenges during development and scale-up.

- Ensure compliance with cGMP, GLP, data integrity, and company quality standards.

- Support regulatory audits, inspections and dossier submission activities.





Preferred candidate profile as below

Qualifications

- M.Pharm (Pharmaceutics preferred).

Experience & Skills

- 6-10 years of experience in Pharmaceutical Formulation R&D.;

- Strong experience in Oral Solid Dosage (OSD) Oncology Development.

- Exposure to regulated markets such as USFDA, EU, Canada, and ROW markets.

- Sound knowledge of QbD, formulation optimization, scale-up, technology transfer, and regulatory requirements.

- Strong analytical, problem-solving, communication, and project coordination skills.

Preferred Profile

- A proactive R&D; skilled with proven experience in oral solid oncology product development, capable of independently managing development activities while effectively collaborating with cross-functional teams.

📌 Assistant Manager / Deputy Manager - FRD OSD - Oncology (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai