ROLE SUMMARY
We are looking for a strong and technically competent ADL professional with extensive hands-on experience in Analytical Development for OSD formulations. The candidate will be responsible for analytical method development, optimization, validation, transfer and troubleshooting for pharmaceutical products, ensuring compliance with ICH, WHO-GMP and applicable regulatory requirements.
KEY RESPONSIBILITIES
- Lead and execute analytical method development for OSD formulations including tablets and capsules.
- Develop, optimize and troubleshoot analytical methods for API, finished products, dissolution, assay, impurities and related substances.
- Handle analytical development activities for new product development, scale-up and technology transfer.
- Develop stability-indicating analytical methods in accordance with ICH guidelines.
- Plan and execute method validation, verification and method transfer activities.
- Perform analytical evaluation of formulation development, exhibit batches, pilot batches and stability samples.
- Evaluate forced degradation studies and establish degradation pathways and stability-indicating capability.
- Strong expertise in HPLC, UV, Dissolution, GC and other analytical techniques.
- Develop and optimize HPLC methods, including column selection, mobile phase optimization and chromatographic conditions.
- Investigate analytical problems, atypical results, OOS/OOT and analytical deviations and provide scientifically sound root-cause analysis.
- Prepare and review analytical method development reports, validation protocols/reports, specifications, STPs and analytical procedures.
- Support CTD/Regulatory documentation and provide analytical data/documentation for regulatory submissions.
- Coordinate with Formulation R&D, IPQA, QC, Production and Regulatory Affairs for successful product development and commercialization.
- Participate in technology transfer from R&D to QC and provide technical support during commercial scale-up.
- Review analytical data, chromatograms, calculations and laboratory documentation for accuracy and compliance.
- Ensure compliance with ALCOA+, data integrity, GDP, GLP, SOPs and laboratory safety requirements.
- Support regulatory/customer audits and inspections related to analytical development activities.
- Identify opportunities for analytical optimization, robustness improvement and laboratory efficiency.
- Guide and mentor junior analytical development scientists and ensure timely completion of project deliverables.
TECHNICAL EXPERTISE REQUIRED
Mandatory strong exposure to:
- OSD Analytical Development
- HPLC Method Development
- Method Validation & Verification
- Method Transfer
- Dissolution Method Development
- Impurity / Related Substance Method Development
- Forced Degradation Studies
- Stability-Indicating Methods
- Analytical Troubleshooting
- OOS/OOT Investigation
- ICH Guidelines
- Regulatory Documentation
- Data Integrity / ALCOA+
- Pharmaceutical QMS
QUALIFICATION
M.Pharm / M.Sc. / B.Pharm / B.Sc. in Pharmaceutical Analysis, Chemistry or relevant discipline.
IDEAL CANDIDATE
The ideal candidate should be a hands-on ADL professional, not purely a documentation-oriented profile, with strong practical knowledge of OSD analytical development, HPLC method development, validation, dissolution, impurities and regulatory expectations.
Candidates from reputed pharmaceutical formulation / OSD R&D organizations with strong Analytical Development exposure will be preferred.
Pay: ₹40,000.00 - ₹80,000.00 per month
Benefits:
- Food provided
- Paid sick time
- Provident Fund
Ability to commute/relocate:
- Baddi, Himachal Pradesh (Baddi): Reliably commute or planning to relocate before starting work (Preferred)
Experience:
Work Location: In person
