Leeladhar Sammatur

Serving as Ass. Director, MS&T to provide technical and scientific leadership through partnerships with site and global functions and third parties to introduce and maintain commercially viable and robust products.

• Directed all company’s lipid based formulation development, process development and scale up activities for both clinical products and collaboration projects. • Directly involved in identifying/qualification GMP raw material vendors from US and Europe for synthetic peptides, oligonucleotides and lipid mixtures for the manufacture of clinical products • Directly involved in qualification/audits for company’s contract manufacturing/analytical sites for manufacture/control analysis (comply to FDA & EU agencies) of sterile freeze dry paranteral drug products • Managed directly all technology transfer, trouble shooting and addressed non conformance issues and involved in closing CAPA • Directly involved in complete characterization of lipid based products with multiple APIs using HPLC techniques, Stability studies & evaluation of vaccine products and anti-cancer drug products • Directing CMC part of IND clinical submissions and Common technical document (CTDs) for CBER,FDA & BGTD, Health Canada and EU by closely working with IMV’s regulatory consultant • Directing set up & analysis of multiple stability studies (both real time and accelerated stability studies) for identifying potential stability & degradation profile of different components of the vaccine formulation • Colloboration works: Effectively managing an annual budget of in excess of $1 million • Leading a team of 10 professionals, including four contractors, ensuring all quality control/assurance support provided to the production processes according to stringent guidelines set down by the European and US Food Drug and Administration (FDA) as per 21 CFR as well as International Conference on Harmonization (ICH).

• Managed and coached diverse group of people such as Development Scientists, Managers and Directors in Formulation/Analytical/Manufacturing for the development/production of recombinant drug substance using fungal/bacterial fermentation and downstream processes. • Managed formulation development for more than 5 investigational new drugs & 4 commercial products (Sterile liquid, freeze dried, solid dosage and emulsions dosage forms) • Key contributor for the success of various manufacturing project proposals and design of the manufacturing processes. • Designed/ developed more than 5 drug product manufacturing processes, scale-up & tech. transfer activities, bacterial vaccines, Cancer therapeutic vaccine (liposome based) • Supported CMC (FDA/Health Canada, EU) 5 clinical trails • Technical contact point (External & Internal) & communicator at all levels in the organization to provide regular and high level update. • Franchise and enterprise-wide responsibility. Management of expense and capital budgets • Manage remote and diverse facilities/sites. • Business experience in Strategic Business Planning, business process engineering, yield improvements

• Involved in process technology transfer, HPLC based testing methodologies • Supported in method validation and process validation • Analyzed and released Development batches and PQ batches for new product release • Set up samples for stability programs and analyzed stability samples • Effectively used electronic note books, eE, Atlas (HPLC instrument control software)

• Analytical method validation for existing analytical testing methods of CVSM (retrospective- validation.). • Performed analytical validation for analytical characteristics like Identification, Quantitation and Assay (content/potency) on instruments like HPLC (Familiar with Empower software), UV/VIS, and Potentiometric Titrators (as per ICH, USP &FDA validation guidelines) • Verification of technology transfers from NOVARTIS-ATLANTA, USA to CVSM and validated stability indicating methods • Involved in investigations like OOS, OOT, LIR and their Corrective and preventive actions.

• Process design and optimization of Fermentation and purification of Vi-Polysaccharide from Salmonella typhi (Ty2)(Process development) • Designed and performed Fermentation and purification of Vi-Polysaccharide for Heamophilous influenza-B conjugate vaccine (conjugated with Tetanus toxoid) from Heamophilous influenza-B bacterial strain. (Process development) • Manufacturing: Extensively worked for 2 years in the commercial production- Fermentation & purification of (up & downstream processing) recombinant protein Hepatitis-B vaccine using various extraction and chromatography techniques • Experienced in product formulation, GMP guidelines and working with regulatory agencies • Involved in regulatory submissions at National drug control, India by closely working with company’s regulatory affairs and also successfully demonstrated the proof of concept for new products • Closely worked with teams for Typhoid& Heamophilous influenza-B vaccine WHO commercial licensing & regulatory submissions

• Extracted and purified connective tissue Chondriotin sulfate from bovine cartilage (product development) • Purification development of Humanchorionic-gonadotrophic (hCG) hormone from pregnant women’s urine (commercial Process optimization)