Analytical Development Executive

Job Description: Analytical Development Executive

Department: Analytical Development / R&D

Industry: Pharmaceutical CMO / Formulation

Location: Mumbai - Malad

Experience: 3 - 8 Years

About the Role

We are looking for an Analytical Development Executive with hands-on experience in pharmaceutical formulation development and analytical method development/validation. The candidate will support analytical activities for CMO/formulation projects, ensuring robust analytical methods, accurate testing, documentation, and timely project execution.

Key Responsibilities

• Develop, optimize, and validate analytical methods for pharmaceutical formulations.
• Perform analytical method development for solid, liquid, and injectable formulations.
• Conduct method validation, verification, and transfer as per applicable guidelines and SOPs.
• Perform testing using HPLC, GC, UV, Dissolution, FTIR and other relevant analytical instruments.
• Develop and optimize analytical methods for assay, related substances, dissolution, content uniformity and other quality attributes.
• Execute forced degradation studies and establish stability-indicating analytical methods.
• Prepare and review analytical protocols, reports, specifications, STPs and related documentation.
• Support analytical method transfer between R&D, QC and manufacturing/CMO sites.
• Investigate OOS, OOT, deviations and analytical discrepancies and support root-cause analysis.
• Review analytical data and ensure compliance with data integrity requirements.
• Coordinate with Formulation R&D, QC, QA, Regulatory and Manufacturing teams.
• Support stability studies and evaluation of stability data.
• Maintain proper documentation in accordance with GMP, GLP and regulatory requirements.
• Support preparation of analytical sections of regulatory and customer/CMO documentation.
• Ensure timely completion of analytical activities as per project timelines.
• Stay updated with current CH, pharmacopoeial and regulatory requirements.
• Travelling to CMO all over India.

Required Qualifications

• M.Sc. / B.Pharm / M.Pharm / equivalent qualification in Pharmaceutical Analysis, Analytical Chemistry or related field.
• 26 years of relevant experience in Analytical R&D / Analytical Development within the pharmaceutical industry.
• Experience in formulation development and/or CMO/CDMO projects will be preferred.
• Strong hands-on experience with HPLC and other analytical instruments.
• Good understanding of analytical method development, validation, transfer and stability studies.
• Knowledge of ICH guidelines, pharmacopoeial requirements and GMP/GLP.
• Strong documentation, analytical problem-solving and communication skills.

Preferred Experience

Candidates with experience in analytical development for generic formulations, contract manufacturing projects, technology transfer, and regulatory submissions will be preferred.

Key Competencies

• Analytical Method Development
• Method Validation & Transfer
• HPLC / GC / UV / Dissolution
• Stability & Forced Degradation Studies
• OOS / OOT Investigation
• GMP / GLP / Data Integrity
• Pharmaceutical Formulation
• Technical Documentation
• Cross-functional Coordination
• Problem Solving

Interested candidate can share their cv on [email removed] or can contact us on [phone removed].