Assistant Manager / Deputy Manager - ARD Oncology

Umedica Labs; Navi Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Umedica Labs in Navi Mumbai is looking for a skilled professional to develop and validate analytical methods for oncology products. The role involves performing various analytical activities, ensuring compliance with regulatory guidelines, and supporting formulation development.

Candidates should have a relevant M.Pharm or Ph.D. and strong technical competencies in analytical methods like HPLC and GC. This position requires collaboration across departments to meet project timelines and support laboratory management.

Qualifications

• Strong experience in analytical method development and validation.
• Sound knowledge of ICH guidelines and regulatory expectations.
• Expertise in impurity profiling and stability studies.

Responsibilities

• Develop, optimize, and validate analytical methods for products.
• Perform and review analytical activities including stability studies.
• Coordinate analytical activities for regulatory submissions.

Skills

Analytical method development

Analytical method validation

HPLC

UPLC

GC

UV-Visible Spectrophotometer

Dissolution Apparatus

ICH guidelines

Regulatory expectations

QbD principles

Education

M.Pharm/Ph.D in Pharmaceutical Analysis

Tools

Analytical instruments

Job description

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

• Strong 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.