Assistant Manager / Deputy Manager - FRD OSD - Oncology

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 professional with proven experience in oral solid oncology product development, capable of independently managing development activities while effectively collaborating with cross-functional teams.