Executive / Sr. Executive – Analytical DevelopmentAbout Us

Axxelent Pharma Science Private Limited is a research-driven pharmaceutical organization committed to delivering innovative, high-quality, and regulatory-compliant solutions for the global healthcare industry.

We are looking for talented professionals to join our Analytical Research & Development (AR&D;) team and contribute to scientific excellence in pharmaceutical analytical method development and characterization.

Position Summary

We are seeking an experienced Executive / Sr. Executive – Analytical Development with strong expertise in Analytical Method Development.

The candidate will be responsible for developing, optimizing, and troubleshooting analytical methods for pharmaceutical products, intermediates, and related substances. The role involves hands-on work with chromatographic and spectroscopic techniques, method validation, method verification, method transfer, stability studies, and preparation of technical documentation in compliance with applicable regulatory guidelines.

The ideal candidate should have strong practical knowledge of analytical instruments, chromatographic techniques, pharmaceutical analysis, and ICH/regulatory requirements.

Key Responsibilities

- Develop and optimize analytical methods for pharmaceutical products, intermediates, APIs, and related substances.
- Perform analytical method development using HPLC, GC, UV-Visible Spectrophotometer, Dissolution, FTIR, and other relevant analytical techniques.
- Develop methods for Assay, Related Substances, Dissolution, Content Uniformity, Identification, and other applicable quality attributes.
- Perform method optimization by evaluating chromatographic conditions such as mobile phase, column chemistry, flow rate, temperature, injection volume, wavelength, and gradient conditions.
- Troubleshoot analytical methods and investigate issues related to peak resolution, tailing, sensitivity, specificity, reproducibility, and system suitability.
- Conduct analytical method validation in accordance with ICH Q2 and applicable regulatory requirements.
- Perform method verification and method transfer activities.
- Support analytical development for stability studies and establish suitable stability-indicating analytical methods.




- Evaluate degradation products and support forced degradation studies for development of stability-indicating methods.
- Perform analytical testing and interpretation of chromatographic and spectroscopic data.
- Prepare analytical method development reports, validation protocols, validation reports, analytical procedures, specifications, and other technical documents.
- Review analytical results and ensure accuracy, completeness, traceability, and compliance with established procedures.
- Support investigation and troubleshooting of OOS, OOT, atypical results, analytical failures, and laboratory deviations.
- Ensure compliance with GMP, GLP, ALCOA+, Data Integrity, and laboratory safety requirements.
- Coordinate with Formulation R&D;, Quality Assurance, Regulatory Affairs, Quality Control, and Project Management teams.
- Support analytical activities associated with product development, scale-up, technology transfer, and regulatory submissions.
- Participate in internal audits, customer audits, and regulatory inspections as required.
- Identify opportunities to improve analytical methods, laboratory practices, and analytical development processes.

Required Qualifications
- M.Pharm
- B.Pharm
- M.Sc – Chemistry / Analytical Chemistry / Pharmaceutical Chemistry

Experience
- 4–7 years of experience in Pharmaceutical Analytical Research & Development / Analytical Development.
- Strong hands-on experience in Analytical Method Development is mandatory.
- Experience in pharmaceutical product development and analytical characterization is preferred.
- Experience with method validation, method verification, method transfer, and stability studies is preferred.

Required Technical SkillsAnalytical Method Development
- Analytical Method Development
- Method Optimization
- Stability-Indicating Method Development
- Forced Degradation Studies
- Related Substances / Impurity Method Development
- Assay Method Development




- Dissolution Method Development
- Analytical Method Troubleshooting
- Method Validation
- Method Verification
- Method Transfer
- Analytical Procedure Development

Instrumentation
- HPLC / UHPLC
- GC
- UV-Visible Spectrophotometer
- Dissolution Apparatus
- FTIR
- Other chromatographic and spectroscopic techniques

Regulatory & Compliance
- GMP
- GLP
- ALCOA+
- Data Integrity
- ICH Guidelines, particularly ICH Q2
- Regulatory requirements for analytical method development and validation
- Knowledge of USFDA, MHRA, EU GMP, WHO-GMP expectations

Documentation
- Analytical Method Development Reports
- Analytical Procedures
- Method Validation Protocols
- Method Validation Reports
- Method Transfer Protocols and Reports
- Stability Study Documentation
- Technical Reports
- Specifications and Test Procedures

Preferred Skills
- Strong hands-on experience in HPLC method development and troubleshooting.
- Good understanding of chromatographic principles and column chemistry.
- Knowledge of impurity and degradation-product profiling.
- Ability to develop robust and specific analytical methods.
- Solid analytical thinking and problem-solving skills.
- Good technical writing and scientific documentation skills.
- Excellent attention to detail.
- Ability to independently plan and execute analytical experiments.
- Good communication and interpersonal skills.
- Ability to work effectively with cross-functional R&D; and Quality teams.

Why Join Axxelent Pharma Science?
- Opportunity to work on innovative pharmaceutical R&D; projects.
- Hands-on exposure to analytical method development and advanced analytical technologies.
- Exposure to global regulatory requirements and pharmaceutical development practices.
- Collaborative and research-focused work environment.
- Opportunities for professional growth and career advancement.

Salary

Best in Industry

Commensurate with qualifications and relevant experience.

Application Process

Interested candidates can share their updated resume to:

[email protected] [email protected]

Ph:(phone hidden)

Pay: ₹10,753.80 - ₹25,088.48 per month

Benefits

- Flexible schedule
- Food provided
- Health insurance
- Provident Fund

Work Location: In person

📌 Executive / Sr. Executive – Analytical Development (Tharamani)
🏢 Axxelent Pharma and Science Private
📍 Tharamani