Chromolution Hiring Analytical Method
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join Chromolution?
- FAQs
- Job Summary Table
Method Validation Scientist – HPLC & GC | Chromolution
Chromolution hiring Analytical Method Validation Scientist (HPLC & GC). BSc/MSc/B.Pharm/M.Pharm, 2–6 yrs exp. Send CV to info@chromolution.com.
Chromolution Research Pvt. Ltd. is seeking a meticulous and experienced Analytical Method Validation Scientist / Analyst with strong hands‑on expertise in HPLC and GC. This role is ideal for analytical chemists and pharmaceutical scientists who are passionate about method development, regulatory compliance, and data integrity — and who want to work in a collaborative R&D / QC environment focused on high-quality analytical outputs.
Company Overview
Chromolution Research Pvt. Ltd. is a fast-growing analytical & formulation services provider supporting pharma, biotech, and CRO projects. We specialize in analytical method development, validation, stability analysis, and regulatory dossier support for domestic and international submissions. Our laboratories follow strict cGMP and GLP practices and use validated chromatographic platforms (HPLC, GC) and industry-standard software to deliver reproducible, regulator-ready data.
Working at Chromolution offers exposure to diverse therapeutic projects, hands-on training on chromatographic instrumentation, and the opportunity to contribute to robust quality systems that underpin patient‑safe medicines.
Job Role & Responsibilities
Position: Analytical Method Validation Scientist / Analyst — HPLC & GC
Key Responsibilities:
- Lead method development and validation projects for HPLC and GC following ICH Q2(R2), USP and regional regulatory requirements (USFDA, EMA, WHO).
- Design and execute validation studies for accuracy, precision, linearity, range, LOD/LOQ, specificity, robustness, and system suitability.
- Prepare, review and maintain validation protocols, SOPs, and validation reports with clear statistical evaluation of results.
- Perform routine and stability sample analysis, ensuring timely, accurate data capture and result reporting.
- Troubleshoot chromatographic issues, perform preventive maintenance and instrument qualification (IQ/OQ/PQ) tasks as needed.
- Ensure compliance with data integrity (ALCOA+) principles, GLP/GMP, and laboratory safety norms.
- Use chromatographic data systems such as Empower, ChemStation, Chromeleon, or OpenLab for data acquisition and reporting; ensure validated software practices.
- Support cross‑functional teams (R&D, QC, Regulatory Affairs) with analytical inputs for product development and dossier submissions.
- Participate in internal audits, respond to CAPAs, and implement corrective/preventive actions to strengthen analytical quality systems.
Eligibility / Qualifications
Education:
- B.Sc / M.Sc (Chemistry) or B.Pharm / M.Pharm (Pharmaceutical Analysis, Analytical Chemistry, Pharmaceutics) — mandatory.
Experience:
- 2–6 years of hands‑on experience in analytical method development and validation specifically using HPLC and GC in a pharmaceutical, CRO, or analytical laboratory setting.
Technical Skills & Knowledge:
- Strong working knowledge of ICH Q2(R2), USP method validation criteria, and stability testing protocols.
- Proficient with chromatographic techniques — method optimization, sample prep, forced degradation studies and stability-indicating method development.
- Experience with chromatographic software: Waters Empower, Agilent ChemStation, Thermo Chromeleon, Agilent OpenLab or equivalent.
- Familiarity with statistical tools for method validation and data analysis (linear regression, RSD, ANOVA where applicable).
- Understanding of instrument qualification (IQ/OQ/PQ) and calibration practices.
Soft Skills:
- Meticulous documentation and technical writing skills.
- Strong troubleshooting and analytical problem‑solving ability.
- Team player with clear communication and cross‑functional collaboration skills.
- Commitment to quality, timelines, and regulatory compliance.
Relevant Courses (comma-separated): Analytical Chemistry, Chromatography (HPLC/GC), Pharmaceutical Analysis, Method Validation (ICH Q2), Stability Testing, GLP/GMP, Instrument Qualification, Data Integrity, Statistical Analysis for Method Validation.
Location & Salary
Location: Chromolution Research Pvt. Ltd. (location as per company site / lab)
Salary: Competitive — aligned with experience, skillset, and industry benchmarks.
Employment Type: Full‑time, permanent
Exact compensation and benefits will be discussed during the hiring process.
Application Process
Interested candidates should email their CV with the subject line “Application – Analytical Method Validation (HPLC & GC)” to:
Email: info@chromolution.com
Please include:
- Updated CV with project details and employment dates.
- One‑page summary of your most relevant method validation project (HPLC or GC) — objectives, approach, major results, and role.
- Notice period and expected CTC.
Shortlisted candidates will be contacted for a technical interview and may be asked to discuss previous validation reports or perform a short practical assessment.
Why Join Chromolution?
- Work in a quality-driven analytical lab with exposure to regulated projects and high‑value dossiers.
- Opportunity to develop expertise in ICH-compliant method validation and stability program execution.
- Access to modern chromatographic platforms and validated data systems.
- Collaborative environment with cross‑disciplinary learning (R&D, QC, Regulatory).
- Contribute directly to product quality and regulatory submissions that impact patient safety.
FAQs
Q1: Is certification required for this role?
Formal certification is not mandatory; however, hands‑on experience and demonstrable method validation projects are essential and valued.
Q2: Which chromatographic software should I be familiar with?
Experience with Empower, ChemStation, Chromeleon, or OpenLab is preferred.
Q3: Will I be required to handle stability samples?
Yes — routine and stability sample analysis is a core part of the role.
Q4: What regulatory guidelines does Chromolution follow?
Chromolution aligns work with ICH, USP, USFDA, EMA, and WHO expectations for analytical data and method validation.
Q5: What should I include in my application?
Include your CV, a one‑page summary of a validation project, notice period, and expected CTC in your email to info@chromolution.com.
Job Summary Table
| Category | Details |
|---|---|
| Company | Chromolution Research Pvt. Ltd. |
| Vacancies | Analytical Method Validation Scientist / Analyst (HPLC & GC) |
| Required Education | B.Sc / M.Sc / B.Pharm / M.Pharm |
| Experience | 2–6 Years (Analytical Method Validation) |
| Location | Company lab / Chromolution site (as specified) |
| info@chromolution.com | |
| Domain | Analytical Method Development & Validation |
To apply for this job email your details to info@chromolution.com
