Assistant Manager - (Oral Solid Oncology)

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

Job summary

Umedica Labs is seeking an experienced professional in Navi Mumbai to develop and optimize oral solid oncology formulations, including tablets and capsules. The candidate will conduct pre-formulation studies, execute scale-up batches, and ensure regulatory compliance.

Applicants should have M.Pharm preferably in Pharmaceutics, with 6–10 years in Pharmaceutical Formulation R&D and strong experience in OSD oncology development. The role involves cross-functional collaboration and adherence to company quality standards.

Qualifications

• 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.

Responsibilities

• Develop and optimize oral solid oncology formulations including tablets and capsules.
• Conduct pre-formulation studies and formulation trials.
• Support development of cytotoxic/high-potency oncology products.

Skills

Analytical skills

Problem-solving skills

Communication skills

Project coordination

Education

M.Pharm (Pharmaceutics preferred)

Job description

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

• M.Pharm (Pharmaceutics preferred).
• 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.