Kalyan Potluri, MBA

Lead new business development across the U.S. East Coast, engaging emerging biotech, mid-size, and large pharmaceutical companies with mid- to late-stage clinical and commercial programs. Promote Siegfried’s global CDMO capabilities with a focus on sterile and oral solid drug product manufacturing while highlighting integrated drug substance services. Key responsibilities include: - Prospect and develop new customer relationships and present Siegfried’s technical and manufacturing capabilities. - Develop and execute New Business Development (NBD) strategies based on market insights and industry trends. - Collaborate with internal technical and commercial teams to evaluate opportunities and prepare proposals. - Support customer visits across Siegfried’s global manufacturing network and contribute to marketing and awareness initiatives. - Coordinate cross-functional stakeholders to align on customer requirements, forecasts, and project execution. - Support contract development with new clients and monitor agreements to ensure compliance and successful partnerships.

Secure business for quality professionals in the following areas: Quality Management Systems Gap Analysis Audits - Internal / External Supplier Quality Documentation

Director, Business Development responsible for administration and management of Adare Pharma Solutions business development efforts on the East Coast of USA. Responsible for identifying, evaluating, structuring, negotiating and closing customer sponsored pharmaceutical product development and manufacturing deals. Execute business development initiatives that are consistent with the company’s overall strategy https://adarepharmasolutions.com/

Director, Business Development responsible for administration and management of Bora Pharmaceuticals business development efforts on the East Coast of USA and Canada. Responsible for clinical and commercial sale of OSD, Topical, Oral liquids and Nasal drug delivery products and services.

Business Development Manager responsible for growing CMC, Product Development and Clinical Manufacturing of Parenterals, Ophtalmics, and Topical dosage forms services division at Exova/Element Exova/Element CMC product development services include: • Pre-formulation and formulation development • Drug/excipient/packaging compatibility • Early stage stability studies for active drug substances and product formulations • Clinical manufacturing (phase I and phase II) • Media Fills • Microbiological development and QC testing • Stability indicating assay development, method validation, and forced degradation studies • Full ICH stability storage and testing • Technology transfers Check the link for more details https://www.exova.com/sectors/pharmaceuticals/cmc-product-development/

Responsible for identifying key stake holders and sale of Almac’s API and Chemical Development services in the USA which include: API services - Small molecule and peptides chemical development and GMP manufacture Preformulation/Solid State expertise Analytical Services Peptide & Protein Technologies Biocatalysis Radiochemistry RAPIDD - integrated IND package (drug substance/drug product/tox/regulatory/QA) For more details please visit: www.almacgroup.com

Responsible for sales of Almac's analytical services in the USA: Primarily responsible for acquiring new and maintaining current customers in - Analytical services - Solid state services - Physicochemical characterization For more details, please visit: www.almacgroup.com

Responsible for the design of formulations for new chemical entities (NCEs) including the identification of methods to optimize the biological performance of molecules with challenging physicochemical properties. Summary of activities Identifying the best physical form of the API desired for drug development based on the physico chemical characteristics. Physical characterising of polymorphs and salts using various bulk and surface characterisation techniques, like; HyperDSC, XRPD, Gravimetric Vapour Sorption (GVS), TGA, microscopy (optical and SEM), BET analysis, HPLC and dissolution testing (intrinsic and non intrinsic methods). Design and execution of experiments to evaluate optimal drug loading within the formulation vehicle as well as understanding the release mechanism of formulations, particularly for oral drug delivery. To provide a link between the API solid form selection and formulation teams. Working with the Physical Sciences, Chemistry and Formulation teams to identify and control the physical form of the API and Drug Product.

Part of the team with the responsibility to develop the drug product and process design for immediate release and modified release oral solid dosage forms which are intended for animal trials and human clinical use. Summary of activities Develop the drug product and process design for prototype and clinical dosage forms to support clinical trials in Phase I, II and III. Liaise with project leaders and Early Development colleagues to ensure appropriate analytical input into projects is delivered, and communicate results effectively.

Member of a team responsible for preclinical formulation development of poorly soluble drugs. Develop methods to determine the drug release, physical and chemical stability of the formulations and API using various thermo analytical techniques. Analytical techniques used Hyper DSC TGA, DVS Raman Dissolution Isothermal calorimeter Malvern laser diffraction HPLC with UV and ELSD detectors SEM BET

Responsible for the manufacture of GMP solid oral dosage forms of API's used for clinical trials using wet/dry granulation and direct compression techniques. Responsible for preparing a monthly material requirement plan (MRP) and also critical item list according to rolling production plan for procurement of materials. Conducted validation of various process equipments (IQ, OQ, PQ) and production process.

Conduct routine analysis of raw materials, intermediates and finished dosage forms. Analytical techniques used Dissolution HPLC GC FT-IR UV/VIS LOD Karl Fisher