Address - **-E City Bangalore

KA ****** INDIA.

Strategic planning for new projects

Scientific knowledge

Team Management

Organization & Interpersonal

Communication

Business Development

AWARDS -

2020- Performance of the Year.

2018- Special employee award.

2016- “Best international publication”

award from Human Biosciences USA.

2015- Best Team Leader.

2014- Best Performance in Development

of Stable Products (contract

manufacturing, HBS USA).

2011- Best performance employee.

2010 - Successful development of

largest no. of products (for contract

manufacturing, HBS USA).

2010 -Best researcher at Ranbaxy –

“Liquid filling in two pieces hard gelatin

capsule”.

ISO 9001:2015, ISO 13485:2016, ISO

14001:2015 – Certified

ENGLISH-CHINESE-MALAY-HINDI-

BAHASA

Key Strengths

Personal Info

PRASHANT K. (LinkedIn click here)

Director-Formulation Development

Johnson & Johnson

(FL, USA)

Scientific Pharmaceutical and Biologics Drug Product Development leader with 15+ years of experience. Expert in formulation of complex injectable, biosimilar and process validation. Optimizations and scale-up from lab to industrial scale. As a CMC lead, responsible for tech transfer and characterization of vaccines and novel class of drug products designed for multifactorial diseases. Planning & execution of R&D and GMP projects. Individual, oversee in-vitro and in-vivo preclinical studies and support regulatory submission. Manage and lead a team of skilled scientists. ady7eh@r.postjobfree.com

Formulation and Validation expert. Developed 65 products -Nanoparticle, Liposomes, Sterile, OSD, mAb.

PhD in Biotech, bachelor and master’s degrees in Pharmaceutics.

Business Management graduate (Finance). Diploma in Computer application.

Hands-on Truvault, Truviewer/TrackWise/ NONMEM/ Pirana / SAP/Biospace software, S4 HANA.

Team leadership and relationship, techno-commercial (training to the marketing team).

Novel Drug Delivery system, Audit response expert, Material Science Expert, CMO/ CRO. Company Starting Years Latest/Last Position Responsibilities July -20

-

Today

2.5

Director of

Formulation

Formulation CMC, Validation, technology

transfer, clinical commercial development

including vendor management, regulatory

submissions, and process improvement.

July-15

-

June-20

5.1

Sr Manager.

Associate Director

Formulation and development, clinical

trial, Monoclonal antibody and insulin

development, validations, QMS

compliance, regulatory submissions, PFS,

medial fill.

April -09

-

June-15

6.2

Research Scientist

Sr Research

Scientist

Formulation and development, Process

Development Process, filter and cleaning

validation Technology Transfer

More than 10 times CDSCO, USFDA, NAFDAC, NPRA, WHO, GMP. More than 5 times PMDA, EMA, EMERGO, ANVISA, NMRA, HAS, CFDA. lesser than 5 times MHRA, TGA, COFEPRIS, NA-DFC.

+91-964*******

Drug Product Formulation -including technical oversight of all drug product process development and validation activities; change activities associated with drug product manufacturing processes; direct external consultants, contract labs, contract supplier technical teams and other external technical resources; development of all supporting documentation for technical products; and development of project timelines aligned to business goals. Author /review IND/CTA/BLA formulation, report to Sr Director of the operation.

Research leader - Lead our upstream and downstream R&D and Scale-Up operations at bench and pilot-scale. Raw material engineering, its selection, cost reduction as per product. Supplier Audit and management program. New products and technologies, Specification and the control of standards.

Key technologies - Solubility enhancement of poorly soluble drugs, stability enhancement, lyophilization. Monoclonal Antibody, complex injectable, oral solid and liquid, ocular, topical dosage form and supplement.

Data Quality and Regulatory, including review and/or prepare all 3.2.P data alongside used in regulatory including pre IND/NDA and other major US/Global regulatory submissions. oversee the compilation of required CMC sections for all required FDA submissions (NDA submissions, annual reports, etc) pertaining to drug product design and improvements. Actively identify and author key SOPS required to enable compliance related to data generation. Clinical trial activities, CRO/CFR, ICH GCP guidance.

Operational Excellence, to include acting as Formulation Subject Matter Expert across the business to impact decision in clinical, non-clinical, regulatory, operations and product development; develop and maintain strong relationships with key stakeholders and external SMEs as needed. Accountability for OpEx and CapEx.

Customer Relationship–Managing CxO relationships towards strategic objectives across organization. Core Audits Qualifications

Accomplishments

Skill Sets

Regulatory Audits

Experience

Program Institution / University Year

PhD (Biotechnology) RGTU, Bhopal MP (INDIA) 2019-23 MBA (Finance) USM, Malaysia 2022-

Leadership USM, Malaysia 2016-17

Diploma in Computer Application SIPS Institute of Technology, Sagar MP (India) 2006-07 B Pharmacy and M Pharmacy RGPV, Bhopal MP (India) 2004-08; 2008-10 Johnson and Johnson (July 2020 – Today)

• Responsible for initiating, directing, and executing scientific research for the development of candidates as like complex injectable, Biosimilars, fill & finish, PFS, OSD, mAb in GMP, FDA approved manufacturing facility.

• Promote and apply design of experiments (DoE), quality by design (QbD) principles to develop robust formulations.

• Directs members of cross-functional teams in the initiation and execution of process development activities, considering economic, 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 successful 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.

[review and approval of MBR, CCs, SOPs, market complaint report, audit report and scientific justifications]

• Noble process development and its validation [Lyophlization process, filter validation up and down stream for mAb].

• Lead quality investigations and data analysis to address deviations, OOS, OOT, non-conformance and implement change controls. CAPA to ensure timely release of batches. Prepare CTD sections for regulatory submissions

• Undertakes short- and long-term planning and supervision of projects Media fill, Insulin Pen, Cartilage

• Giving scientific input during client meetings for Formulation Development work and supporting the Formulation Scientist during scientific discussions. The delivery of robust, scalable, and cost-effective manufacturing

• Provides supervision and technical support for manufacturing processes in laboratory and manufacturing plant.

• Supports, actively participates in CMC and Sub-teams for commercial products and development projects as required.

• Problem solving, both for R&D and GMP Production, from technical issues (e.g. equipment) to scientific 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.

• Review and approve Formulation Development reports, Technical Batch reports and GMP Manufacturing reports. Providing input on and reviewing Statements of Work (work offers)

• Facilitating Tech Transfer from ‘R&D mode’ to ‘GMP level’

• Responsible for the people management of a team of around 20 scientists including recruitment and training of new team members.

• Supporting in Technical Sales (Business Development), guiding the client towards the most suitable formulation strategy. Biocon Biologics Malaysia (July 2015-June 2020)

Product and Process Development

Insulin Glargine, Insulin 30 :70, Monoclonal antibody, OSD and complex injectable.

Leaded a team of Process Development scientists responsible for pre-clinical and clinical manufacturing.

Solubility enhancement, stability enhancement, CMO / CRO collaboration.

Team Development and leadership.

On time product release. On time QMS closure (Deviation, OOS, OOT). Validation Activities

Process validation and continues process verification.

Filter validation, manual visual inspection. Media fill, Cleaning in place

Worked cross functionally with teams and manage communication with external CMO/CROs, multiple direct reports.

Analysed and summarize essential data to present in meetings for regulatory purposes

Generate/maintain core dossiers and maintain a comprehensive understanding of FDA, ICH, EU guidelines and regulations pertaining to Regulatory Affairs.

Academics

Work Experience Details

Ranbaxy Laboratory- India (April 2009-June 2015).

Research and Development

Developed plan, and oversee DP development and manufacturing programs, including projection of DP material requirements, budgets, and timelines.

Managed Contract Development and Manufacturing Organizations (CDMOs) for process technology transfer and optimization, non GMP and cGMP manufacture of DP in support of ongoing clinical programs.

Executed plans in accordance with cGMP, ICH, and FDA regulations.

Partner with and maintain regular contact with key stakeholders including, Discovery, Quality Assurance, Regulatory Affairs, Finance, and Program Management. Write and review relevant sections for regulatory submissions.

Leaded preparation and review of CMC sections related to IND and NDA submissions. Attend meetings with FDA, EMEA and prepare responses to agency questions.

Served as the SME for designing and optimizing manufacturing processes taking consideration of speed, quality, cost, scalability.

Prashant Khemariya, Ankit Agrawal and Elango Minnoor. “Formulation of Dispersible Ayurvedic Kadha Tablet for the Management of Cold and Cough”, Japanese Journal of Medical Research, Volume 1, Issue 1, pp. 1-7, (May 2023)

Prashant Khemariya, Dr. Ankit Agrawal and Dr. Elango Minnoor. “Filter Integrity Test for Aseptic Processing” in Global Academic Journal of Pharmacy and Drug Research Vol-4, Iss-4 pp- 89-93 (September 2022).

Khemariya P, Agrawal A and Minnoor E. “An Overview of Ayurveda” in Journal of Natural & Ayurvedic Medicine Vol 6 Issue 3. 1-12 (July 2022).

Khemariya P, Agrawal A, Kumar K and Tiwari AK “Quantitative Analysis of Eugenol in Different Parts of Clove” in Journal of Natural & Ayurvedic Medicine 2022, 6(3): 000359 (August 2022).

Pravin K Patel, Dr. Jaya Sharma, Dr. Shivali Kharoliwal, Dr. Prashant Khemariya “The Effects of Nobel Corona Virus (Covid-19) in the Tourism Industry in India”; International Journal of Engineering Research & Technology, Vol. 9 Issue 05, May-2020; 780-788.

Prashant Khemariya “A way to denature Novel Corona Virus” a proposal was accepted by WHO and US based committee in Feb 2020.

Pravin Kumar Patel, Jaya Sharma, Shivali Kharoliwal and Prashant Khemariya “What is the Impact of Coronavirus on Indian Economy? - A Review” Acta Scientific Volume 4 Issue 8 August 2020, 03-09.

Prashant Khemariya “New era of cell engineering- IN-VITRO cell (Keratinocytes) culture and its IN-VIVO application on wounds’’ speaker participant in 2nd International Conference on Pharmaceutical Research & Innovations in Pharma Industry May 30-31, 2019 Orlando, Fl USA.

Prashant Khemariya, Kaushal Dubey and Richa Khemariya, “Innovative approach to sustain the release of the drug from conventional dosage form- Nifedipine SR Tablet” Journal of Nanomedicine and Nano Science JNAN 115, Volume 2017 Issue 02.

Khemariya Prashant, Khemariya Richa and Jain Amit, “An exclusionary approach to recover iron deficiency by POLYROL an over view of iron polymaltose complex" International Journal of Advanced Research in Biological Sciences, Vol 3, Issue 4–2016, 188.

Prashant S Khemariya and Richa P Khemariya “Comparative Evaluation of Efficacy of Pure Collagen Type I Based Modern

Dressing with Conventional Dressing in the Treatment of Burn and Diabetic Foot Ulcer” in International Journal of Current

Research in Biosciences and Plant Biology (Feb. - 2016).

Prashant S Khemariya and Richa P Khemariya “New-Fangled Approach in the Management of Alzheimer by Formulation of Polysorbate 80 Coated Chitosan Nanoparticles of Rusvastigmine for Brain Delivery and their in-vivo Evaluation” in International Journal of Current Research in Biosciences and Plant Biology (Feb.- 2016).

Prashant S Khemariya “Formulation of Iron coated Liposomes of SERM and design development of magnetic belt for the management of breast cancer during earlier stages and protection from invasive cancer” accepted by International Drug Delivery Submit 2015, An international conference in Houston USA.

Prashant Khemariya Solubility enhancement of Pimobendan by co solvency and co crystallization method. A novel approach to enhance the solubility of poorly soluble drug in syrup dosage form accepted in international journal of Drug delivery and science.

Prashant Khemariya, Rajan John, Ragani Maharotra, Rajani Paramhas “An overview – How to be safe and healthy Pregnancy” published in Earth Journal of Social Science- January-2015 ISSN 231*-****-** Volume 3.

Choubey Shivani, Vyas Suresh Prasad and Khemariya Prashant “Effective antibiotics and ATP loaded delivery System in the management of Diabetics wound” in Int. J. Curr. Microbiol. App.Sci (2013) 2(9).

Prashant K and Amit K J “An innovative approach to prolong gastric retention “Floating microspheres of cimetidine hydrochloride” in Global Advanced Research Journals (August-2012).

P. Khemariya “A Pioneering Approach to Enhance Dissolution and Bioavailability of Multiple Drugs in a Single Dosage Form: Speedy Disintegrating Tablet of Cefpodoxime Proxetil and Potassium Clavulanate” in Journal of Advanced Scientific Research (July-2012).

Research Paper - Novel approach to enhance bioavailability of poorly aqueous soluble drugs- “Liquid Filing in Two Piece Hard Gelatin Capsule” in 2nd Conference- Innovation in Drug Delivery: From Preformulation to Development through Innovative Evaluation Process in France (Dec10).

P. Khemariya, M. Bhargava and S. Goswami “Preparation and In-Vitro Evaluation of Sustained-Release Matrix Tablets of Diltiazem” Published in International Journal of Advances in Pharmaceutical Sciences (October-2010).

P. Khemariya and S. Goswami “Formulation and Characterization of Sustained Release Gastro Retentive Drug Delivery System of Ofloxacin” Published in International Journal of Advances in Pharmaceutical Sciences (October-2010).

P. Khemariya, A. Jain, R. Goswami and Mohit Bhargava- “Advances in Novel Drug Delivery Carriers: Formulation and In Vitro Evaluation of Solid Lipid Nanoparticles of Nateglinide” International Journal of Pha’cal and Applied Sciences (June-2010).

Prashant Khemariya, and Mohit Bhargava- “An emerging trend in tablet technology: - Floating Tablets of Ranitidine HCl” Published in International Journal of Drug Delivery (May -2010).

Prashant Khemariya, Mohit Bhargava and Sanjay Goswami - “Preparation and evaluation of “Mouth Dissolving Tablets of Meloxicam” Published in International Journal of Drug Delivery (Jan -2010).

Prashant Khemariya, Rajesh S. Jadon, Swadesh Nayak, Sabita Amlan, Vikas Deep Vaidya, Sandip Sumbhate, S. Nayak. - “Taste Masking of Lornoxicam by Polymer Carrier System and Formulation of Oral Disintegrating Tablets” Published in Inter. Journal of Drug Delivery May 09.

Prashant Khemariya - “An overview of Drug Receptor Interaction” Published in Journal of Pharmacology (March-2006). Research Publications - 30

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