Analytical Development Scientist (ADL)

Why This Role Matters
Analytical Development plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products before they reach patients. In a regulated environment where precision and compliance are non-negotiable, robust analytical method development and validation form the backbone of successful product approvals and commercial manufacturing.
At Corona Remedies Limited, this role directly supports product innovation across women’s healthcare, cardio-diabeto, pain management, urology, and other therapeutic segments. By developing and validating reliable analytical methods, the Analytical Development Scientist ensures regulatory compliance, smooth technology transfer, and consistent product quality throughout the lifecycle.
Working at the Bhayla manufacturing facility in Gujarat provides exposure to a high-performance, cGMP-compliant environment focused on operational excellence and scientific rigor.

Job Description
We are seeking an experienced and detail-oriented Analytical Development Scientist to join the Analytical Development Lab (ADL) at the Bhayla Plant, Gujarat. The selected candidate will be responsible for developing, validating, and transferring analytical methods in line with ICH, cGMP, and GLP requirements.
The role requires strong technical expertise in chromatographic and spectroscopic techniques, structured documentation practices, and cross-functional collaboration with Formulation R&D and Quality Control teams. The candidate must demonstrate strong analytical thinking, regulatory awareness, and problem-solving skills in a commercial pharmaceutical environment.

Key Features of the Role
• Hands-on exposure to analytical method development and validation
• Work with advanced analytical instrumentation (HPLC, UPLC, GC, UV, FTIR)
• Involvement in CTD/DMF documentation and regulatory submissions
• Collaboration with R&D and QC for technology transfer
• Opportunity to contribute to product scale-up and commercial manufacturing
• Work in a cGMP-compliant manufacturing environment

Responsibilities
• Develop, validate, and verify analytical methods for assay, dissolution, and related substances as per ICH guidelines
• Operate analytical instruments including HPLC, UPLC, GC, UV, FTIR, and Dissolution Apparatus
• Prepare and review analytical protocols, validation reports, and routine documentation
• Generate Certificates of Analysis (COA) and support CTD/DMF compilation
• Ensure compliance with cGMP and GLP documentation standards
• Collaborate with Formulation R&D for method development during product development
• Transfer validated analytical methods to Quality Control for scale-up and commercial production
• Investigate and resolve analytical deviations, OOS, and OOT results
• Maintain data integrity and adherence to regulatory standards
• Participate in internal audits and regulatory inspections as required

Required Qualifications

Educational Requirements:
• M.Sc / M.Pharm / B.Pharm in relevant scientific disciplines

Experience and Skills:
• 2 to 8 years of experience in Analytical Development within the pharmaceutical industry
• Hands-on experience in method development and validation
• Strong working knowledge of ICH guidelines and regulatory expectations
• Practical exposure to chromatographic and spectroscopic instruments
• Experience in a regulated manufacturing environment
• Strong documentation, analytical reasoning, and problem-solving skills
• Ability to work cross-functionally with R&D and QC teams

Salary Insights
The compensation package is competitive and aligned with industry benchmarks for analytical development professionals in Gujarat. The expected salary range is approximately ₹4,00,000 to ₹12,00,000 per annum (CTC), depending on experience, technical proficiency, and regulatory exposure.
Benefits typically include health insurance, performance incentives, structured career progression pathways, and opportunities for professional growth within a quality-driven pharmaceutical organization.

Company Overview
Corona Remedies Limited is a leading pharmaceutical organization known for its focus on women’s healthcare, cardio-diabeto, pain management, and urology segments. The company operates advanced manufacturing facilities in Gujarat (including the Bhayla plant) and Himachal Pradesh.
With a strong emphasis on cGMP compliance, innovation in formulations, and quality excellence, the organization continues to expand its capabilities in research, development, and commercial production.

FAQs

• Is prior ADL experience mandatory?
Yes, relevant experience in analytical development within a pharmaceutical setup is required.

• What type of products will I work on?
Primarily pharmaceutical formulations across key therapeutic areas handled by the company.

• Is regulatory documentation exposure important?
Yes, familiarity with CTD/DMF documentation and compliance standards is highly preferred.

• Where is the job located?
Bhayla Plant, Gujarat.

Application Tips
• Highlight hands-on experience with HPLC, UPLC, and method validation projects
• Emphasize regulatory compliance knowledge (ICH, cGMP, GLP)
• Include examples of analytical issue resolution or method transfer experience
• Demonstrate documentation accuracy and audit readiness
• Showcase collaboration with R&D or QC teams