Manager / Sr. Manager - (Oral Solid Oncology)

Umedica Labs; Navi Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Umedica Labs in Navi Mumbai is seeking a candidate for leading formulation development of Oral Solid Oncology products. The role requires expertise in oncology product formulation, regulatory compliance, and the ability to manage multiple projects in a high-performing team.

The ideal candidate will possess an M.Pharm or Ph.D. in Pharmaceutics, with hands-on experience in product development for regulated markets such as USFDA and EMA.

Qualifications

• 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.

Responsibilities

• Lead formulation development of Oral Solid Oncology products.
• Design and optimize formulations using QbD principles.
• Drive development of cytotoxic/onco products, ensuring compliance.

Skills

Pharmaceutical Formulation R&D

Oncology Formulation Development

Oral Solid Dosage Products

Regulatory Compliance

Education

M.Pharm / Ph.D. in Pharmaceutics

Job description

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.