Role & responsibilities

- Develop, optimize, validate, and transfer analytical methods for solid oral, liquid, and injectable oncology products.
- Perform and review analytical activities including assay, related substances, dissolution, content uniformity, residual solvents, and stability studies.
- Execute forced degradation studies and establish stability-indicating analytical methods.
- Prepare and review analytical protocols, reports, specifications, SOPs, and technical documents.
- Support formulation development through analytical troubleshooting and scientific evaluation of development batches.
- Coordinate analytical activities for scale-up, exhibit batches, technology transfer, and regulatory submissions.
- Investigate OOS/OOT results, support root cause analysis, and implement CAPA actions.
- Ensure compliance with cGMP, GLP, GDP, data integrity, and oncology safety procedures.
- Coordinate with Formulation R&D;, Quality Assurance, Regulatory Affairs, Production, and external laboratories to achieve project timelines.
- Support laboratory management, equipment qualification,



and continuous improvement initiatives.

Educational Qualification

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

Technical Competencies

- Robust experience in analytical method development and validation using HPLC, UPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, and related analytical instruments.
- Sound knowledge of ICH guidelines, pharmacopoeial requirements (USP/EP/IP), and regulatory expectations for USFDA, EU, and global markets.
- Expertise in impurity profiling, forced degradation studies, stability studies, and analytical troubleshooting.
- Hands-on experience in analytical method transfer, specification setting, and CMC documentation support.
- Knowledge of QbD principles, analytical risk assessment, and data interpretation.

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

📌 Assistant Manager / Deputy Manager - ARD Oncology (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai