Role & responsibilities

- Lead formulation development of Oral Solid Oncology products (tablets, capsules, modified-release formulations) from concept to commercialization.
- Design and optimize formulations using QbD principles, pre-formulation studies, and excipient compatibility assessments.
- Drive development of cytotoxic/high-potency oncology products, ensuring compliance with safety and containment requirements.
- Oversee scale-up activities, including pilot, exhibit, validation, and commercial batches, and facilitate seamless technology transfer to manufacturing.
- Prepare and review development reports, regulatory documentation, and dossier support for US market
- Collaborate cross-functionally with Analytical R&D;, Regulatory Affairs, Production, QA, Procurement, and Packaging teams to achieve project milestones.
- Manage multiple projects, ensuring timely delivery, effective risk mitigation,



and resolution of formulation/process challenges.
- Lead, mentor, and develop a high-performing formulation team, fostering innovation and technical excellence.
- Ensure compliance with cGMP, GLP, data integrity, and quality standards, and support regulatory audits and inspections.

Preferred candidate profile

- M.Pharm / Ph.D. (Pharmaceutics preferred).
- 1214 years of experience in Pharmaceutical Formulation R&D.;
- Minimum 68 years of experience in Oncology Formulation Development.
- Hands-on experience in Oral Solid Dosage (OSD) Oncology Products.
- Experience in development for regulated markets such as USFDA, EMA, MHRA, Health Canada, and other global markets.

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

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