Leading a team of highly educated professionals with BS, MS and PhD degrees in pharmaceutical and Biotech CDMO, development, and cGMP technology transfer.

Heading Analytical/ Development**************************************Leading a team of highly educated professionals with BS, MS and PhD degrees in pharmaceutical and Biotech CDMO, development, validation and cGMP technology transfer. Concept to Commercialization.

• New product scale up and process development. pFMEA (process failure mode of effect analysis), Risk assessment, Project, Process, People, Timeline management to ensure project management.• Cross -functional liaison with stakeholders from different departments. Identified and mitigated risks and critical paths ensuring smooth progress of the project. Teams included supply chain, raw material procurement, quality, commercial, R&D and global teams.• Responsible for pharmaceutical cGMP manufacturing tech transfer at Allergan plant as a receiving and sending unit.• Aseptic processing, Sterile solutions and Ointment products, Ophthalmic products marketed globally.• Trackwise, change controls, investigations, deviations, facility fit, scale up, formulation etc.• Responsible for multi dose and unit dose filling line qualification activities activities. Responsible for bringing the multi processing skids online to up to date the manufacturing technology.• Process validation and continuous process validation of pharmaceutical compounding and filling operations. Process included dry powder mixing, bulk heat sterilization, sterile filtration and sterile filling operations. Cleaning validation.• Site preparedness for audits by regulatory agencies ensuring quality and compliance in day-to-day operations.

• Responsible for method development, validation of therapeutic molecules testing process. Purity, characterization, charge heterogeneity, aggregation, binding etc. assays.• Lead group of scientists for cGMP release testing of a commercial parenteral products. Mentoring, training and development of younger scientists, trouble shooting technical problems and excursions.• Responsible for stability testing program, market release, performance and clinical testing in a regulated setup.• Contributed to 24/7 GMP compliance readinesses for FDA (21 CFR), EMA, MHRA, ANVISA and other regulatory agencies. Abreast with guidelines in ICH Q2A, Q2B.

• Responsible for the technology transfer of pharmaceutical products from Pfizer to Boehringer Ingelheim in a cGMP setting.• Responsible for process development and scale up of biopharmaceuticals• Involved in projects, reports, regulatory filing with multi departmental teams including members from QA/ QC/ Validation, R&D, Process engineering, Capital engineering, Maintenance, Manufacturing, Regulatory, Planning, Logistics, Blending, Filling, Sales and Purchasing in a cGMP plant.• Abreast with latest in process development and validation guidelines, process analytical techniques (PAT) for real time monitoring of manufacturing processes, DoE, QbD and lean manufacturing approaches.• Experience with proposal writing, regulatory filing, cGMP documents, SOPs, Forms and Dossier. EHS, OSHA, EPA policy adherence.• Direct experience with MAPICS and PRISM as an enterprise-resource-planning tool in a manufacturing plant.

• Executed bioprocess engineering and scale-up the recovery and purification of therapeutic recombinant proteins (Factor IX) and antibodies.• Analyzed biologics with a combination of bioanalytical, immunological and biophysical methods for protein degradation, activation, posttranslational modifications (gla, glycan etc. analysis). Designed immunological and enzymatic assays, prepared novel biomarkers. Protein-polymer conjugation for improved pharmacokinetics.• Responsible for technology transfer, cGLP/GMP manufacturing and process analytical techniques for preclinical and clinical trials.

* Purified of recombinant/ transgenic proteins and other biologics including Factor IX, growth hormones, synthetic peptides, and synthetic oligonucleotides.* Responsible for downstream purification including preparative chromatography, filtration, process development and validation, regulatory aspects, maintenance and trouble shooting of instruments.* Analyzed biologics using protein assays, gel-electrophoresis and CE, western blotting, IEX and RP HPLC, MS, MALDI, MS/MS etc.* Responsible for business development, market know-how, sales support and customer interactions at leading biotech companies, technological presentations at customer site and on international conferences.* Designed, synthesized and evaluated displacers used in displacement mode chromatography with applications in analytical and preparative separation, impurity profiling, lot analysis of biomolecules.

•Over-expression of proteins and selenomethionine substituted protein in E. coli host cells.•Wide ranging experience in purification and analysis of proteins by selective precipitation and chromatography techniques (FPLC and HPLC).•Responsibilities including radiation control (32P), setup and maintenance of lab instruments including photon counting spectrofluorometer, HPLC, FPLC and established new standard operating procedures (SOPs).•Strong background in the enzyme kinetics, gel-electrophoresis, activity essays, protein structure/function studies, and bioanalytical and biophysical characterization of bio-molecules in general and restriction endonucleases in particular.•Training of lab personnel, graduate and undergraduate students.

•Structure/Function studies of molecular models of the active sites of pyranopterin-dithiolate molybdenum and tungsten enzymes •Operate and maintain photoelectron spectrometer (PES), Bruker X-ray Diffractrometer, NMR, IR, UV-Vis, GC/MS instruments.•Chemical synthesis of inorganic, organic and organometallic compounds. •Spectroscopic techniques (NMR (1D (1H/13C) and 2D including COSY, HMQC, TOCSY, NOESY, ROESY), EPR, IR, UV-Vis, PES etc.) and small molecule X-ray diffraction.•Computational chemistry including density functional theory, molecular modeling.•Hands on experience in biological EPR, rR, molecular biology experiments.•Science with a business perspective; courses like “Foundations of business for scientists”, “Project management” and “Topics in entrepreneurship for scientists” taken at the Eller College of Management, and “Biotech Startups” taken at College of Law.