Role & responsibilities

- Lead analytical method development, optimization, validation, verification, and transfer for oncology formulations across solid oral, liquid, and injectable dosage forms.
- Develop and review analytical protocols, reports, specifications, method validation documents, and stability study documentation.
- Provide scientific support for formulation development, process optimization, troubleshooting, and product lifecycle activities.
- Ensure timely execution of analytical activities including assay, related substances, dissolution, content uniformity, impurity profiling, and stability studies.
- Manage analytical activities for exhibit batches, scale-up batches, technology transfer, and regulatory submission requirements.
- Review analytical data, investigate OOS/OOT results, support CAPA implementation, and ensure data integrity compliance.
- Coordinate with Formulation R&D;, Quality Assurance, Regulatory Affairs, Production, and external laboratories for successful project execution.
- Ensure compliance with cGMP, GLP, GDP, ICH guidelines, and oncology safety/containment procedures.
- Lead, mentor, and develop analytical scientists and ensure effective utilization of laboratory resources.
- Drive continuous improvement initiatives, laboratory compliance,



and implementation of recent analytical technologies.

Educational Qualification

- M.Pharm / Ph.D. Pharmaceutical Analysis) or equivalent qualification from a recognized university.

Technical Competencies

- Strong expertise in analytical method development and validation for pharmaceutical dosage forms.
- Hands-on experience with analytical instruments such as HPLC, UPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, and related laboratory equipment.
- Thorough knowledge of analytical techniques for assay, impurities, degradation products, residual solvents, and stability studies.
- Strong understanding of ICH guidelines, pharmacopoeial requirements (USP/EP/IP), and regulatory expectations for USFDA, EU, and other global markets.
- Experience in analytical method transfer, technology transfer, specification setting, and CMC documentation.
- Knowledge of forced degradation studies, stability-indicating methods, QbD principles, and analytical risk assessment.
- Expertise in handling oncology/high-potent products (HPAPI) and adherence to containment and safety practices will be preferred.

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

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