Hiring for R&D Synthesis, AMD, ARDL Department at FDC India

A leading pharmaceutical company is expanding its team! We specialize in manufacturing Ophthalmics, Oral Liquids, Oral Powders, and Topical Powders, with each production section housed in a dedicated facility. Our Ophthalmics section features three State-of-the-Art Blow-Fill-Seal (BFS) machines, catering to Regulated and Semi-regulated markets.

HIRING Officer / Sr. Officer

R&D Synthesis (API) Department
Key Responsibilities
• Primary lab synthesis work and lab maintenance.
• Literature work related to lab projects.
• Documentation of R&D process
• Preparation of related documents for technology transfer of developed processes.
• Process validation and transfer to technology transfer department.
• To modify the process or method of preperation for betterment.
• Achieving targets within time limits.
Requirements : M.Sc. in Chemistry 2-6 Years of relevant Experience

AMD (Analytical API) Department
Key Responsibilities
• Timely analysis and reporting of Raw materials, intermediates, standard and finished products of projects in R&D Synthesis.
• Usage of analytical instruments like UPLC HPLC GC UV IR, polarimeter, under cGMP environment.
• Hand on experience in wet analysis of API and intermediates.
• Daily calibration of analytical instruments in stipulated time.
• Stability studies of ongoing projects in R and D as per timeline.
• To perform analytical method development and analytical method validation study.
• Technology transfer support to production site.
Requirements : M.Sc. in Chemistry 2-6 Years of relevant Experience

ARDL (Analytical Formulations) Department
Key Responsibilities
1. Complex Ophthalmic :
• Perform analytical testing for ophthalmic emulsions, suspensions, gels, and solutions.
• Conduct tests for assay, impurities, pH, osmolality, viscosity, droplet size distribution, zeta potential, and preservative content.
• Support analytical method development, optimization, validation, and troubleshooting.
• Participate in stability studies and compile data for regulatory submissions.
2. Peptide Products :
• Conduct analytical testing and characterization of peptides including API and formulations.
• Perform analysis using RP-HPLC, SEC, IEX, amino acid profiling, and peptide mapping techniques.
• Address specific challenges like peptide aggregation and stability under ICH conditions.
3. Q3 Similarity (Product Development Support) :
• Perform critical Q3 characterization tests (e.g., globule size distribution, rheology, pH, osmolality, surface tension) to support development of ophthalmic and peptide-based products.
• Generate Q3 comparative data against Reference Listed Drugs (RLDs) for bioequivalence justifications.
• Assist in preparing Q3 similarity reports for regulatory submissions and respond to agency queries.
• Collaborate with formulation development team to interpret analytical data and support formulation optimization based on Q3 findings.
Requirements : M.Sc. in Chemistry 3-6 Years of relevant Experience