Analytical Development Executive

Archerchem Healthcare; Mumbai Suburban; On-site; INR 800,000 - 1,100,000; Full time

Benefits offered by this job

Travel for India CMO coordination

Job summary

Archerchem Healthcare is seeking an Analytical Development Executive in Mumbai to lead analytical method development and validation for CMO/formulation projects. The role covers method transfer, stability studies, and collaboration across R&D, QC, and manufacturing teams.

The candidate will handle HPLC, GC, UV, dissolution, and FTIR analyses, ensure data integrity, and support regulatory documentation. A strong background in pharma analysis and GMP/GLP is essential.

Qualifications

• MSc/Pharm degree in Pharmaceutical Analysis 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 preferred.
• Strong hands-on experience with HPLC and other analytical instruments.
• Knowledge of ICH guidelines, pharmacopoeial requirements and GMP/GLP.
• Excellent documentation and communication skills.

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 guidelines and SOPs.
• Perform testing using HPLC, GC, UV, Dissolution, FTIR and other analytical instruments.
• Develop and optimize methods for assay, related substances, dissolution, content uniformity and other quality attributes.
• Execute forced degradation studies and establish stability-indicating 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; support root-cause analysis.
• Review analytical data and ensure data integrity compliance.
• Coordinate with Formulation R&D, QC, QA, Regulatory and Manufacturing teams.
• Support stability studies and evaluation of stability data.

Skills

Analytical Method Development

Method Validation & Transfer

HPLC / GC / UV / Dissolution

Stability Studies

OOS / OOT Investigation

GMP / GLP / Data Integrity

Pharmaceutical Formulation

Technical Documentation

Education

M.Sc. / B.Pharm / M.Pharm / equivalent qualification in Pharmaceutical Analysis, Analytical Chemistry or related field

Job description

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