: 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.
- Robust 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 protected] or can contact us on 90288 71352.

📌 Analytical Development Executive (Mumbai)
🏢 Archerchem Healthcare
📍 Mumbai