Dr Prashant S Khemariya Email & Phone Number

Bengaluru, Ka, In

Ernakulam, Kerala, India

❖ Manage a team of brillant scientists. Direct members of cross-functional teams in the initiation and execution of formulation, process development activities, process optimization and validation (process and cleaning).❖ Responsible for initiating, directing, and executing scientific research for the development of a drug products like complex injectable, Biosimilars, fill & finish, PFS (Pen and cartridge), OSD, cosmetic-beauty product, mAb in GMP, FDA approved manufacturing facility.❖ Promote and apply design of experiments (DoE), quality by design (QbD) principles to develop formulations regulatory and safety factors (acting as a scientific support in R&D projects).❖ Responsible for developing pharmaceutical products from “End to End” and leading to successfulPMTA/NDA/ANDA filings and approval in a timely manner through internal or external sources, to promote company’s goals for US and global markets.❖ Management of external CDMOs under cGMP and regular auditing, finalization of CROs/CMOs/CTLs /CDMO Serve as technical contact and SME for technology transfer QMS elements.❖ Independently plan, execute, and manage regulatory submissions in CTD/ eCTS (PDA, REACH/ ECHA, EU, IMPD, IND, MAA) for assigned compounds in various phases of development, global marketing applications and post-approval activities.❖ Noble process development and its validation [Lyophilization process, filter validation up and mAb].❖ Lead quality investigations and data analysis to address deviations, OOS, OOT, non-conformance andimplement change controls. CAPA to ensure timely release of batches. Prepare CMC sections for regulatory challenges (e.g. formulation/process development) and quality/GMP related issues.❖ Keep up to date with drug delivery and formulation technologies, Evaluate and implement new technologies, equipment and manual visual inspection. Hands on HPLC/UPLC, MFI, DSC, DLS, DSF.

India

Technical Services Director

Malaysia

Responsible for activities related to - Formulation - CMC, Fill Finish, Media Fill, AVI, MVI, QMS(mAb, upstream/downstream, Insulin, single/multi dose fill finish formulations).Function as a lead and subject matter expert in investigation of Deviation, support in vaccine manufacturing.Demonstrate high level of leadership and expert understanding of global regulations and guidelines by applying interpersonal skills and expert knowledge to address and overcome challenges that arise during development and commercialization (Support investigation in Deviation/OOS/OOT, Change control, CIP, SIP and Component Preparation).Independently plan, execute and manage regulatory submissions (PDA, EU, IMPD, IND, MAA and NDA) for assigned compounds in various phases of development, global marketing applications, and post-approval life cycle activities.As member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/ ISO/GHTF Global regulations compliance with QMS, procedures, and controls within the organization. Oversee manufacturing, process, and QC laboratory equipment qualification lifecycle including DQ/IQ/OQ/PQ, summary reports, validation periodic review. Verify and/or execute Factory Acceptance Test (FAT), Site Acceptance Test (SAT).

Malaysia

with Hovid and KCK PharmaResponsible to lead, manage and motivate a team of brilliant scientists, from pre-formulation till the commercialization of a wide range of drug products (upstream/ downstream), into a cGMP Manufacturing environment.Evaluated literatures, patents, reference product profile and monograph and develop non-infringement strategies for upcoming products. Process Analytical Technology (PAT) implementation and life cycle management (CPP/CQA/CMA).Followed QbD & DoEPerformed pre-formulation study, feasibility, FMEA, Analysis, stability study (as per ICH/ASEAN/NPRA) Leaded in control of all manufacturing process steps by a validated DCS (Distributed Control System) and LIMS (Laboratory Information Management System), provide support in CMC, analytical method development (TLC, HPLC, UV, Micro & GC).Involved in preparation of trial and pilot scale batches in pilot lab to determine a suitable and robust process which will yield stable product at the commercial site. Provide support on the soft floor during production and troubleshooting.Developed technologies like, Nanoparticles, co-solvency, dendrimer, Spheronization, Palletization co-crystallization, Lyophilization, for improvement of solubility and stability of poor drugs. Taste masking of bitter drugs for applications.Technology transfer from laboratory to the soft floor. Scale-up (SUPAC) and thorough process validation as per FDA guidance (review, approval of validation docs). Assist in executing development study plan for NDA and ANDA Filling.Provided technical leadership on Validation and master control as per 21CFR 11, 210 & 211, 600-680, PIC/S.Equipment validation (DQ/IQ/OQ/PQ, process validation, MVP, cleaning, filter and filling validation hold time study for products and equipment, protocol, report and scheme). deviation and audit reply report as per FDA, GMP, cGMP. Maintain high level of scientific & technical knowledge within the team for TGA, CFDA, PMDA norms

Dewas Area, India

• Followed QbD/DoE concepts for development as per FDA guidance • Evaluation and approval of all documents per USFDA, GMP, cGMP, GLP.• Stabilized type I collagen at RT and developed various products (patches, antiaging cream, silver nanoparticles etc.)• Developed new technologies & advanced in Lyophilization, Ophthalmic, Parenteral, oral liquid / solid (syrup, suspension) or semisolid formulations by defining target, product profile (from cost, quality manufacturing point).• Process developed and optimized including scale-up for commercialization - Spheronization, Pelletization, Coating, MUPS and all Dosage form.• Conducted pre formulation study of tablet, capsule, and injectable.• Developed liquid filling process in two peace hard gelatin capsule.• Conducted stability study on lab scale batches and interpret data to develop sound conclusions. Planned and executed daily research activity.• Developed alternative process for existing product to reduce the cost. Involved in the approval of API and Excipients suppliers and audited their manufacturing facility. Played a key role in technology transfer to other sites.

Dewas Area, India

 Followed QbD concepts for development as per FDA guidance  Evaluation and approval of all documents per USFDA, GMP, cGMP, GLP. Stabilized type I collagen at RT and developed various products (patches, antiaging cream, silver nanoparticles etc.) Developed new technologies & advanced in Lyophilization, Ophthalmic, Parenteral, oral liquid / solid (syrup, suspension) or semisolid formulations by defining target, product profile (from cost, quality manufacturing point). Process developed and optimized including scale-up for commercialization - Spheronization, Pelletization, Coating, MUPS and all Dosage form. Conducted pre formulation study of tablet, capsule, and injectable. Developed liquid filling process in two peace hard gelatin capsule. Conducted stability study on lab scale batches and interpret data to develop sound conclusions. Planned and executed daily research activity.

Doctor Of Philosophy - Phd, Biotechnology, 8

Master Of Pharmacy, Pharmaceutics, 1St

Activities and Societies: Master"Formulation and Characterization of Sustained Release Gastroretentive Drug Delivery System of Ofloxacin.

Bachelor Of Pharmacy, Pharmacy

High School Certificate, Pcm

Activities and Societies: SchoolingSchooling

Bachelor Of Laws - Llb, Criminal Justice/Law Enforcement Administration