Bharathwajan Narayanan Email & Phone Number

United States

Mumbai, Maharashtra, In

Glenmark Pharmaceuticals Limited is a research-led, global organization committed to enriching lives.I’ve been promoted multiple times at Glenmark due to the number of process improvement initiatives implemented, my brownfield and greenfield experience, and development of talent.I have built and currently manage an operations team with a safety-first culture. Our team manages production for aseptic processing pre-filled syringes and vial products for filling and commercialization.I also currently spearhead remediation activities for sterile operations involving the complete requalification of Facility, Utilities, and Equipment systems including successful completion of several Aseptic Process simulation (Aerobic Media fill) batches post remediation activities with zero non-conformance.I’ve also supported the design phase and worked on ORABS and CRABS through development and initiations of risk assessment tools like FMEAs and HACCP.In addition to a culture of safety, I lead a culture of efficiency and we’ve seen dramatic reductions in wasted time and improved manufacturing operations.

Mumbai, Maharashtra, In

I was promoted and led 2 teams of 41 total employees for a 24x5 3-shift operation in the OSD and single shift sterile operations.I hired staff, drove performance, and managed workflows to consistently meet CGMP standards. I alsoidentified continuous improvement projects, managed production product P&L and budgets, andoptimized department resources.I directed and supported the formulation, evaluation, strategy, and presentation of product and processsolution improvements.I also served as a key leader for remediation activities.

Mumbai, Maharashtra, In

I was promoted and managed a team of 12 to execute the 1 st Exhibit Batch filling of the site for the FDA’s approval.I planned and maintained the budget, trained staff, and monitored KPIs for continuous improvementinitiatives.We launched our 1st commercial OSD product for the site on-time. I also streamlined our operationsteam into a 3-shift commercial operation to meet demand and ANDA filings.

Mumbai, Maharashtra, In

I joined Glenmark to qualify and validate OSD and Sterile Injectable Operations Facility Utilities andEquipment systems.I led production in several batches of critical controlled release formulations, prepared budgets, andmonitored to reduce deviations during exhibit batches.We successfully executed the 1st exhibit batch filling on the site for FDA approval and the successfulimplementation and DEA approval of controlled substances infrastructure (C-II Vault).I was also the site SME on smoke study for facility qualification, Aseptic behaviors, technology transfer,and ERP systems.

Silarx was a manufacturer and marketer of liquid generic pharmaceutical products.I spearheaded new facility qualification for a successful completion of a newly acquired facility validationwith FDA’s cGMP approval.We strategically selected and developed solid dosage products for the generic market. I also oversawthe technology transfer of over 12 liquid solution and suspension dosage products at the new site.

Patent and publication research on brand drug product for prototype formula developmentDevelopment of initial pre-formulation studies on API [solubility studies, pH, flow properties, particle size distribution, Density (Bulk & tapped)] and drug-excipients compatibilityDetermining the optimum process for the development of suitable solid dosage form (based on pre-formulation characteristics of the API) such as wet granulation, dry granulation, direct compression approach or encapsulationIdentifying the quality target product profile (QTPP) from the pre-formulation studies and RLD characterization. Setting up the critical quality attributes (CQA) throughout the product development. Planning and execution of lab-scale batches to develop and optimize stable & robust formula for further final scale-upInterpretation of stability data by evaluating the impurity levels. Periodic communication with Stability and AR& D for evaluation and interpretation of dataExecution of ANDA/Bio batch as per the optimized process of the final scale-up batchesPreparation of scientific documents like batch records, product development report for FDA submissionInterpretation of in-vivo study data of Bioequivalence/ Bioavailability data

Authoring and reviewing of Standard Operating Procedures (SOPs) for ChemistsCalibration of analytical instruments (HPLC, UV, Dissolution apparatus etc)Analyses of samples for identification, assay, impurity levels and dissolution from various sources such as R& D, stability, QC in-process and Finished productsHand-on experience on various analytical instruments like HPLC, UV-Vis, FTIR, Distek dissolution apparatus, Karl Fisher, O'Haus moisture balance. Writing and self reviewing of laboratory notebooks, calibration notebooks, log-books

Analysis of Pre-clincial toxicology and pharmacology results of a Monoclonal Antibody.

• Developed Non-clinical studies on Parkinson's disease• Designed animal models to establish Oxidative stress induction on rat brain• Performed surgical removal of drug tested rat brain• Prepared and analyzed affected brain cell samples for estimating the oxidative damage caused by rotenone and quantified the same by ROS level, blood MDA level, and Nature of cell death which were estimated using FACS caliber (flow cytometry)• Conducted MCAO surgery in rats for Ischemia –Reperfusion animal models

Masters, Biotechnology

Bachelor Of Pharmacy - Bpharm, Pharmacy

Bachelors, Pharmacy