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MANISH SETHI, Ph.D., M.B.A.

RTP, NC

859-***-**** www.linkedin.com/in/sethimani add673@r.postjobfree.com PROFILE

• Over 8 years of experience in research, development, commercial operations and regulatory strategy

• Project management involving multiple projects, scope, feasibility timeline and new product introduction

• Diverse academic, research and development background: Chemistry, Bio-Pharmaceuticals, Business management

• Product development: Formulation to Scale up manufacturing involving QbD, Statistical DOE, CMC filings

• Lean Six Sigma Yellow Belt Certified

ACCOMPLISHMENTS

• Led projects teams at different facilities: research labs, startup and commercial manufacturing units

• Published 18 research papers (1 cover article), 16 presentations, a patent and a book chapter

• Spearheaded strategies for multi-disciplinary projects involving Tech Transfer and commercial launch

• Earned multiple academic and research awards

SKILLS

M.B.A. – Strategy, Finance, Analytics (GPA: 3.9) EDUCATION Indiana University (Kelley), Bloomington

2018-2020

Ph.D. – Chemistry (GPA: 3.8) 2007-2011

University of Kentucky, Lexington, KY, USA

Thesis: Surface interactions of biomolecules with gold NPs PI: Marc R. Knecht, Ph.D

M.S. – Biomedical Sciences 2005-2007

University of Delhi (ACBR), New Delhi, India

B.S. (Honors) – Microbiology 2002-2005

University of Delhi, New Delhi, India

PROFESSIONAL EXPERIENCE

TERGUS PHARMA

Durham, NC

Sr. Manager, Tech Transfer (MS&T) 12/2019 – 05/2020

• Set up teams and implemented new processes for product development, tech-transfer, CQA and CPP determination, optimization, SUPAC, registration, process validation (PPQ), and commercial launch

• Managed technical relationship between sending and receiving organizations, campaign monitoring and support, batch records, data interpretation, performance analysis and investigation support

• Spearheaded market research for new products from concept, feasibility, regulatory risks and guidelines, IP, market analysis, potential customer demand, forecasting, scenario analysis, pricing and launch strategies

• Led cross-functional tech transfer teams as a project manager for GLP and GMP commercial projects

• Strategic Planning, Problem solving, Systemization, driving cross-functional collaborations and SOPs

• Accelerated learning: ability to perform in a

fast-paced environment, and taking initiatives

• Data Analytics: Minitab, JMP, Stata, Excel • Business needs and Risk Assessment, FMEA, CI

• Biopharmaceutical processing and purification • Process optimization: R&D to GMP manufacturing

• Product management and Customer service:

from development to commercial launch

• Simulations, Forecasting, Scenario Analysis,

P&L/NPV, COGS Analysis

• QbD Tech-Transfer, Scale up, DOE, Process

Optimization, Validation and On-market support

• Cellular, OSD, Semi-solids, Parenteral, Nano-

formulations: Small molecules and Biologics

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MAYNE PHARMA

Greenville, NC

Tech Transfer Lead 04/2016 – 11/2019

• Led process strategies, designs, QbD plans, and supply chain for tech transfer and commercial manufacturing

• Drove multiple projects in-house, for clients and at CMOs ensuring product quality- by coordinating with the functional heads in Pharm. Dev, QA, Supply Chain, Regulatory, Manufacturing and Packaging Operations

• Led product development through all phases, tech-transfer, risk-mitigation strategies, process optimization, scale-up, registration, process validation (PPQ), commercial launch, and on-market support

• Assisted in process validation, equipment IQ/OQ/PQ, CI initiatives, deviations, root cause analysis, CAPAs

• Continuous Process Verification efforts for existing products and new transfers

• Maintained an understanding of the current FDA and ICH guidelines related to CMC and SUPAC activities CATALENT PHARMA SOLUTIONS

Winchester, KY

Associate Development Scientist 01/2015 – 04/2016

• Client interface for OSD formulation, product & process development using CQAs and CPPs

• Led project execution involving risk assessment, design, manufacturing, batch records, protocols and reports

• Collaborated with QC, QA & engineering teams for design parameters, resolving process discrepancies

• Managed multiple projects within budgetary and timeline restrictions VINDICO PHARMACEUTICALS

Lexington, KY

Senior Formulation Scientist 03/2014 - 01/2015

Led bench-scale parenteral formulation projects:

• Polymersomes based biologics formulation development

• Cancer vaccine development using peptide-polymer conjugates

• Gold nanoparticle-based gene delivery system targeting microbial and cancer cells UNC-CHAPEL HILL

Chapel Hill, NC

Postdoctoral Research Associate 08/2011 - 03/2014

Managed preclinical formulation projects:

• Cancer vaccine development using peptide-polymer based nanoparticles

• Targeted drug delivery for poorly soluble small molecules using lipid formulations

• Gene delivery using viral vectors and nanoparticles

• Chemo-Radio-Sensitization using combination of targeted drug delivery and radiation Tech Transfer and Market Research

• Internship: Carolina KickStart entrepreneurial team: Initial risk assessment of a novel technology's limitations, regulatory and technical risk, IP and market feasibility SELECTED AWARDS

• Second prize (team), GSCB Consulting Case Competition, University of Virginia 2014

• Postdoctoral Leadership Award, UNC-Chapel Hill 2013

• Best Poster Award, UNC-Chapel Hill 2012

• Outstanding Graduate Student Research Award, University of Kentucky 2010

• Presidential Fellowship, University of Kentucky 2010 - 2011

• Research Challenge Trust Fund Fellowship, University of Kentucky 2008 - 2010

- Both fellowships awarded to outstanding research students

• Fast Start Award, University of Kentucky 2008

• Catch them Young Scholarship Award, C.S.I.R, India 2005 and 2006

- Awarded to students with outstanding academic merit per year Page 3 of 5

SERVICE AND LEADERSHIP

• Outreach Coordinator of UNC Graduate Consulting Club 2013 - 2014

• Co-chair of postdoctoral association, UNC-Chapel Hill 2013 - 2014

• Secretary to the Graduate Student Association 2009 – 2010

• Reviewer to several high impact scientific journals 2011-Present Memberships: American Association for Cancer Research American Association of Pharmaceutical Scientists

Reviewing member: Journals

Journal of Biomedical Nanotechnology Materials Letters Biomaterials Analytical Bioanalytical Chemistry Clinical Breast Cancer Journal of Controlled Release PUBLICATIONS

Peer-Reviewed Journals

1. Delany, S.P.; Nethercott, M.J.; Mays, C.J.; Winquist, N.T.; Arthur, D.; Calahan, J.L.; Sethi, M.; Pardue, D.S.; Kim, J.; Amidon, G.; Munson, E.J. Characterization of Synthesized and Commercial Forms of Magnesium Stearate Using Differential Scanning Calorimetry, Thermogravimetric Analysis, Powder X-Ray Diffraction, and Solid-State NMR Spectroscopy. J. Pharm. Sci. 2017, 106, 338. 2. Sethi, M.; Caster, J. (co-first); Kowalczyk, S.R.; Wang, E.; Tian, X.; Hyder, S.N.; Wagner, K.T.; Zhang, Y.; Kapadia, C.; Au, K.M.; Wang, A.Z. Nanoparticle delivery of chemosensitizers improve chemotherapy efficacy without incurring additional toxicity. Nanoscale. 2015, 7, 2805. 3. X. Tian, H. Lara, K. Wagner, S. Saripalli, S. Hyder, M. Foote, Sethi, M.; E. Wang, J. Caster, L. Zhang, A. Wang. Improving DNA double-strand repair inhibitor KU55933 therapeutic index in cancer radiotherapy using nanoparticle drug delivery. Nanoscale. 2015, 7, 20211. 4. Sethi, M.; Sukumar, R. (co-first); Karve, S.; Werner, M.E.; Moore, D.T.; Kowalczyk, S.R.; Zhang, L.; Wang, A.Z. Effect of Drug Release Kinetics on Nanoparticle Therapeutic Efficacy and Toxicity. Nanoscale. 2014, 6, 2321.

5. Wang, E.C.; Sinnott, R.; Werner, M.E.; Sethi, M.; Whitehurst, A.W.; Wang, A.Z. Differential cell responses to nanoparticle docetaxel and small molecule docetaxel at a sub-therapeutic dose range. Nanomed. Nanotechnol. Biol. Med. 2014, 10, 321.

6. Werner, M.E.; Cummings, N.D. (co-first); Sethi, M.; Wang, E.C.; Sukumar, R.; Moore, D.T.; Wang, A.Z. Preclinical Evaluation of Genexol-PM, a Nanoparticle Formulation of Paclitaxel, as a Novel Radiosensitizer for the Treatment of Non-Small Cell Lung Cancer. Int. J. Radiat. Oncol. Biol. Phys. 2013, 86, 463. 7. Sethi, M.; Merrill, N.A. (co-first author); Knecht, M.R. Structural and Equilibrium Effects of the Surface Passivant on the Stability of Au Nanorods. ACS Appl. Mater. Interfaces. 2013, 5, 7906. 8. Karve, S.; Werner, M.E.; Sukumar, R.; Cummings, N.D.; Copp, J.A.; Wang, E.C.; Li, C.; Sethi, M.; Chen, R.C.; Pacold, M.E.; Wang, A.Z. Revival of the Abandoned Therapeutic Wortmannin by Nanoparticle Drug Delivery. Proc. Natl. Acad. Sci., U.S.A. 2012, 21, 8230. 9. Sethi, M.; Law, W.C.; Fennell, W.A III; Prasad, P.N.; Knecht, M.R. Employing Materials Assembly to Elucidate Surface Interactions of Amino Acids with Au Nanoparticles. Soft Matter 2011, 7, 6532. 10. Sethi, M.; Pacardo, D.B.; Knecht, M.R. Biological Surface Effects of Metallic Nanomaterials for Applications in Assembly and Catalysis. Langmuir 2010, 26, 15121. (Cover Article of the October 5, 2010 issue)

AFFILIATIONS

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11. Pickin, K.A.; Ezenwajiaku, N.; Overcash, H.; Sethi, M.; Knecht, M.R.; Paumi, C.M. Suppression of YCF1P Function by CKA1P-Dependent Phosphorylation is Attenuated in Response to Salt Stress. FEMS Yeast Res. 2010, 10, 839.

12. Sethi, M.; Knecht, M.R. Understanding the Mechanism of Amino Acid-Based Au Nanoparticle Chain Formation, Langmuir 2010, 26, 9860. Listed as one of the most read article in Langmuir for April 2010. 13. Coppage, R.; Slocik, J.M.; Sethi, M.; Pacardo, D.B. Naik, R.R.; Knecht, M.R. Elucidation of Peptide Effects that Control the Activity of Nanoparticles, Angew. Chemie, Int. Ed. 2010, 49, 3767. 14. Sethi, M.; Knecht, M.R. Experimental Studies on the Interactions between Au Nanoparticles and Amino Acids: Bio-Based Formation of Branched Linear Structures, ACS Appl. Mater. Interfaces 2009, 1, 1270. Listed as a top 20 most read article in ACS Appl. Mater. Interfaces for June 2009. 15. Pacardo, D.B.; Sethi, M.; Jones, S.E.; Naik, R.R.; Knecht, M.R. Biomimetic Synthesis of Pd Nanocatalysts for the Stille Coupling Reaction, ACS Nano 2009, 3, 1288. 16. Knecht, M.R.; Sethi, M. Bio-Inspired Colorimetric Detection of Hg2+ and Pb2+ Heavy Metal Ions Using Au Nanoparticles, Anal. Bioanal. Chem. 2009, 394, 33. 17. Sethi, M.; Joung, G.; Knecht, M.R. Linear Assembly of Au Nanorods Using Biomimetic Ligands, Langmuir 2009, 25, 1572.

18. Sethi, M.; Joung, G.; Knecht, M.R. Stability and Electrostatic Assembly of Au Nanorods for use in Biological Assays, Langmuir 2009, 25, 317.

Book Chapters

1. Sethi, M.; Knecht, M.R. Amino Acid Mediated Linear Assembly of Au Nanomaterials. In NanoBiotechnology Protocols, 2nd Edition, Sandra J. Rosenthal and David W. Wright, Ed.; Humana Press: New York, NY, 2013; ISBN 978-1-62703-467-8.

Patents

1. S. Mitra, D. Kumar, D. Saluja, M. Sethi. Fluorescent core shell organically modified silica (ORMOSIL) nanoparticles based detection probe and kit for Cryptococcus neoformans. IN Patent India 906 / DEL / 2009. PRESENTATIONS

Scientific Conferences

1. Manish Sethi, R. Sukumar, S. Karve, N. D. Cummings, M. E. Werner, A. Z. Wang. Tunable Drug Release of Polymeric Nanoparticles for the Delivery of DNA Double-strand Break Repair Inhibitors. 54th Annual ASTRO Meeting, Boston, MA, October 28 - 31, 2012.

2. Manish Sethi, Rohit Sukumar, Shrirang Karve, Michael E. Werner and Andrew Z. Wang. Nanoparticle Drug Release Kinetics can Affect Their Toxicity and Therapeutic Efficacy. UNC Lineberger Annual Postdoc Day, Chapel Hill, NC, October, 11, 2012.

3. Manish Sethi and Marc R. Knecht. Surface Interactions Between Biomolecules and Au Nanoparticles. Regional ACS Meeting, 2010 CeRMACS, Dayton, OH, June 16 – 19. 2010. 4. Manish Sethi, GaEun Joung, and Marc R. Knecht. Surface Interactions Between Biomolecules and Au Nanoparticles. 2009 Annual Meeting of the Kentucky Academy of Sciences, Northern Kentucky University, November 13 – 14, 2009.

Posters

1. Manish Sethi, Harry Cocolas, JoEllen Early. Abbreviated Design of Experiments Used in the Technical Transfer of a Modified-Release Multi Particulate Capsule. AAPS, Orlando, Fl, October 25-27, 2015. Page 5 of 5

2. Manish Sethi, Sonya R. Kowalczyk, Chintan H. Kapadia, Michael E. Werner, Rohit Sukumar, Edina Wang, Andrew Z. Wang. Nanoparticle Chemosensitization. 55th Annual ASTRO Meeting, Atlanta, GA, September 22

- 25, 2013.

3. Manish Sethi, Sonya R. Kowalczyk, Chintan H. Kapadia, Michael E. Werner, Rohit Sukumar, Edina Wang, Andrew Z. Wang. Nanoparticle Chemosensitization. Gordon Conference on Cancer Nanotechnology; Mount Snow Resort in West Dover VT, July, 14 – 19, 2013. 4. Manish Sethi, Sonya R. Kowalczyk, Chintan H. Kapadia, Michael E. Werner, Rohit Sukumar, Edina Wang, Andrew Z. Wang. Nanoparticle Chemosensitization. 2013 UNC Lineberger Oliver Smithies Nobel Symposium; Chapel Hill, N.C, April 19, 2013. Won 1st Prize among 45 presenters. 5. Manish Sethi, Sonya R. Kowalczyk, Chintan H. Kapadia, Michael E. Werner, Rohit Sukumar, Edina Wang, Andrew Z. Wang. Nanoparticle Chemosensitization. American Association of Cancer Research (AACR) Annual Meeting 2013; Washington, D.C, April 6-10, 2013.

6. Manish Sethi, Rohit Sukumar, Shrirang Karve, Michael E. Werner and Andrew Z. Wang. Cross-linkable Lipid Shell Polymeric Nanoparticle with Tunable Drug Release for the Delivery of Therapeutics with High Potential Toxicity. 2012 UNC Lineberger Scientific Retreat; Chapel Hill, N.C, May 23, 2012. Won 3rd Prize in Clinical Translational category

7. Manish Sethi, Rohit Sukumar, Shrirang Karve, Michael E. Werner and Andrew Z. Wang. Cross-linkable Lipid Shell Polymeric Nanoparticle with Tunable Drug Release for the Delivery of Therapeutics with High Potential Toxicity. NCI Annual Site Visit – Carolina Center of Cancer Nanotechnology Excellence; Chapel Hill, N.C, March 14, 2012.

8. Manish Sethi and Marc R. Knecht. Assembly Pattern of Au Nanoparticles Elucidates Biomolecular Surface Interactions. 2011 Naff Symposium on Chemistry and Molecular Biology; Lexington, KY, April 8, 2011. 9. Manish Sethi and Marc R. Knecht. Surface Interactions Between Biomolecules and Au Nanoparticles. 2010 Naff Symposium on Chemistry and Molecular Biology; Lexington, KY, April 23, 2010. 10. Manish Sethi, GaEun Joung, and Marc R. Knecht. Surface Interactions Between Biomolecules and Au Nanoparticles. 238th ACS National Meeting, Washington, D.C., August 16-20, 2009. 11. Manish Sethi, GaEun Joung, and Marc R. Knecht. Biomolecular-Based Assembly of Au Nanoparticles. 2009 Naff Symposium on Chemistry and Molecular Biology; Lexington, KY, April 25, 2009. 12. Manish Sethi, GaEun Joung, and Marc R. Knecht. Stability and Electrostatic Assembly of Au Nanorods for use in Biological Assays. 2008 Naff Symposium on Chemistry and Molecular Biology; Lexington, KY, April 4, 2008.

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