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NJ Bio, Inc. (formerly NJ Biopharmaceuticals LLC d/b/a NJ Bio) is a leading Contract Research Organization (CRO)/ Contract Development and Manufacturing Organization (CDMO) headquartered in Princeton, NJ, with additional chemistry facilities in Bristol, PA and Mumbai, India. Our focus is on providing integrated chemistry and biology services to companies in the biotech and pharmaceutical sectors. We offer an extensive range of services built on our expertise in bioconjugation, synthetic organic chemistry, and protein-based biopharmaceuticals. NJ Bio’s Core Service Areas include:
Antibody-Drug Conjugates (ADCs) and Bioconjugation: Expertise in bioconjugation to proteins and biomaterials, express bioconjugation, innovative linker chemistry design for conjugations, novel payload-linker technology, ADC construct development, process development for both small molecules and ADCs.
Protein and Antibody Production: High-quality production of research-grade proteins and antibodies, targeted protein degrader optimization, target protein degrader conjugates.
Cell-Based Functional Assays: Expertise in performing various functional assays, including 2D & 3D cytotoxicity, ADCC (antibody-dependent cell-mediated cytotoxicity), ELISA, ADC stability, and pharmacokinetic (PK) analysis.
Nucleotide and Oligonucleotide Synthesis: Precise creation of nucleotides and DNA molecules for research and therapeutic development, custom oligos, modifications, conjugation, and purification.
mRNA synthesis: High-quality, IVT mRNA sequence synthesis and incorporation of modified nucleotides.
Bioanalytical services: State-of-the-art instrumentation, team of skilled analysts, broad range of services, including in vitro metabolic stability assay using LC-MS, rapid PK analysis, ligand binding assays and LBA-LC-MS Hybrid Approach.
These services expand our capacity to offer customized solutions, enhancing our dedication to excellence for clients in the biotech and pharma sectors.
NJ Bio’s mission is to be a beacon of excellence in contract research, development and manufacturing, by providing cutting-edge biopharmaceutical and advanced chemistry services. We strive to establish long-lasting collaborations with our clients by consistently empowering them to accelerate their product development projects. Our top priority is to offer efficient, cost-effective, and timely solutions that cater to our clients’ varying needs, thereby delivering exceptional value. Our dedication to teamwork, confidentiality, and reliability drives us forward, and we continuously innovate to overcome complex research, development and manufacturing challenges. Customer satisfaction is the heart of our mission.
OUR PEOPLE AND CULTURE
At NJ Bio, our people and culture are the driving forces behind our success, ensuring that we consistently provide cutting-edge solutions to our clients while maintaining the highest standards of quality, efficiency, and adaptability. We are proud to have a team of highly talented and experienced laboratory chemists and biologists who are driven by their unwavering passion for science, resulting in innovative, client-focused solutions. This deep dedication to their work sets us apart, resulting in the creation of unique and tailored programs that address our clients’ needs with excellence. Above all, our scientists are committed to delivering high-quality services in a cost-effective and timely manner.
Our corporate culture is built on the principles of collaboration, communication, and adaptability. We understand the significance of working together as a cohesive unit to achieve remarkable results. Our work culture fosters a dynamic exchange of ideas and insights, leading to creative problem-solving and breakthroughs.
Nareshkumar Jain, Ph.D. – President, CEO and Chairman
Dr. Jain is the founder, CEO, and Chairman of the Board at NJ Bio. He is also a member of Robin Hood Ventures, a leading Mid-Atlantic investment group. Prior to founding NJ Bio in 2018, Naresh served as Global Head of Chemistry and Senior Vice-President of ADC Biomanufacturing at Abzena. In 2009, he founded the chemistry based CRO, The Chemistry Research Solution LLC (TCRS), and served for six years as Managing Director of the company until its acquisition by Abzena in late 2015. Naresh has over ten years of medicinal chemistry experience at Johnson and Johnson, where he worked on advancing new drug molecules from early lead to lead optimization and clinical trials. He has co-authored over 60 publications, patents, and book chapters. Among his notable achievements are the total syntheses of complex natural products including the antibiotics vancomycin and rutamycin. Naresh received his Ph.D. from Boston University with Prof. James Panek and was a Post-Doctoral Research Fellow at The Scripps Research Institute in La Jolla, California with Prof. K.C. Nicolaou. Naresh received extensive leadership training through the Advanced Management Program at The Wharton School of The University of Pennsylvania.
Ralf Mueller, Ph.D. – Chief Business Officer
Dr. Mueller is NJ Bio’s Chief Business Officer and his responsibilities include the company’s overall business development, proposal management, and marketing activities. Ralf has more than twenty years of experience working for chemistry and biopharmaceutical CROs and CDMOs, covering the fields of business development, custom synthesis, process development and cGMP manufacturing. His previous positions include Senior Executive Director of Business Management with NJ Bio, Senior Director of Business Development with Abzena, Senior VP of Chemistry & Business Development with The Chemistry Research Solution LLC as well as Director of Chemistry with Alchem Laboratories Corporation. Ralf received his doctor title in organic chemistry from the University of Freiburg, Germany, and then worked as Postdoctoral Associate with Prof. Raymond Bergeron at the University of Florida on the synthesis of a “Hypusine reagent” and polyamine analogues. He has co-authored 15 research articles on potential drugs against cancer (i.e., polyamine antiproliferatives), dyslipidemia (i.e., long hydrocarbon chain acids and diols, related to bempedoic acid), and other topics.
Libu Mathew, B.S., CPA – Chief Financial Officer
In his role as NJ Bio’s Chief Financial Officer, Libu is providing financial guidance and related executive support to NJ Bio’s administrative operations. Libu is an experienced finance professional, specialized in accounting and Generally Accepted Accounting Principles (GAAP) with more than twelve years of work experience in diverse financial positions at several companies in the healthcare manufacturing and service sectors. Libu also has a background as a financial auditor and previously headed the Accounting Department of a major car parts manufacturing company in Philadelphia. Libu obtained his bachelor’s degree in Business Administration from Drexel University, Philadelphia, and is certified as a Public Accountant in the Commonwealth of Pennsylvania.
Priya Nayak, Ph.D. – Vice-President, Global Operations
Priyashri (Priya) Nayak is Vice-President of Global Operations and a Board Member at NJ Bio, Inc. Priya was an angel investor with Robin Hood Ventures and has supported investment in family-owned entrepreneurship companies and sports clubs. Priya has 23 years of broad experience in global consumer healthcare companies including Glaxo SmithKline, Pfizer, Johnson & Johnson, Bayer, and Prestige Labs, as well as with a start-up company, The Chemistry Research Solution (acquired by Abzena). She has led technical teams that successfully developed and commercialized global products for brands such as Aleve PM®, Bayer® Aspirin®, Aspirin® plus C, Alka-Seltzer®, Benadryl®, Sudafed® Listerine®, Bengay®, Tums®, and Citrucel®, contributing to over a billion dollars in sales. Priya received her Ph.D. in Industrial Pharmacy from the Massachusetts College of Pharmacy & Allied Health Sciences, Boston, and a Masters in Pharmaceutical Sciences from University Department of Chemical Technology (now ICT), Mumbai.
Megan San Juan – Vice-President, Quality Operations
Megan San Juan joined NJ Bio as the Vice-President of Quality Operations in January 2024. With over 25 years of hands-on experience in the pharmaceutical and biopharmaceutical industry, Megan has provided regulatory quality and compliance oversight to clinical and commercial manufacturing operations. Megan began her pharmaceutical career in 1994 as an Analyst in the Chemistry laboratory and retired from Pfizer Inc., in August 2022 after serving in various quality and compliance roles at both site and corporate levels.
Megan has made significant contributions as the quality leader of five biopharmaceutical manufacturing sites, overseeing the production of aseptic and non-aseptic human and animal drugs, vaccines, gene therapy, and combination products. Additionally, she has led a team of Contract Quality Leaders responsible for quality and compliance activities at contract manufacturers, packagers, and service providers in North America and the European Union. Megan has a proven track record of delivering on commitments and achieving high performance.
Megan holds a Bachelor of Science degree in Chemistry from the University of San Carlos in Cebu City, Philippines, as well as a Bachelor of Science degree in Manufacturing Technology and Business Quality Management from Southwestern College in Wichita, KS University. She is also a US Army veteran and serves as a mentor for American Corporate Partners (ACP), the only nonprofit organization focused on national corporate career counseling for returning veterans and active-duty military spouses. ACP aims to facilitate the transition from the military to the civilian workforce by connecting veterans and military spouses with corporate professionals for customized mentorship. Megan is dedicated to supporting individuals in their pursuit of fulfilling, long-term careers. In addition to her professional pursuits, Megan is an avid gardener and runs an industry consulting firm and a coffee business.
Julien Dugal-Tessier, Ph.D. – Vice-President, Innovative Chemistry & Bioconjugation
Dr. Julien Dugal-Tessier joined as Director and is now Vice-President of Innovative Chemistry & Bioconjugation. Julien has over 10 years of Antibody-Drug Conjugates (ADCs) research experience. In his successful ADC research career at ImmunoGen, Agensys/ Astellas and NJ Bio, Julien focused on the design of novel payloads and linkers. At ImmunoGen, he studied potent DNA damaging agents with the goal of increasing their therapeutic index. Prior to ImmunoGen at Agensys (a former affiliate of Astellas), Julien worked on a variety of different payloads and linkers which led to four product candidates, one of which (AGS62P1) is currently in a Phase 1 clinical trial. Julien was also involved in the discovery-to-scale-up activities of ADC payloads and linkers as well as in chemistry activities supporting later stage programs such as the commercially approved ADC, Enfortumab Vedotin. Julien obtained his Ph.D. from the University of British Columbia in a joint project between Profs. Gregory Dake and Derek Gates on the development of metal catalysis for organic synthesis. After his Ph.D., Julien studied N-heterocyclic carbene catalysis and its application towards a total synthesis during his post-doctoral fellowship at Northwestern University with Prof. Karl Scheidt.
David Fry, Ph.D. – Distinguished Research Leader
Dr. Fry joined NJ Bio as Distinguished Research Leader in early 2019. David has expertise in NMR analysis of proteins, peptides, and small molecules; structure elucidation and confirmation by NMR; protein analysis; ligand-binding studies by NMR; and 2D and 3D multinuclear NMR experiments. Prior to joining NJ Bio, he served for three years as Vice-President of Protein Chemistry at The Chemistry Research Solution LLC. David has 27 years of drug discovery experience as Head of Structural Chemistry at Hoffmann-La Roche and is a globally recognized expert in the use of NMR to discover small molecule drugs for protein-protein interaction (PPI) targets. David’s research highlights include pioneering work on Interleukin-2 inhibitors, the Ras-binding domain of c-Raf, design of a PYY peptidomimetic (clinical candidate), and an essential role in the discovery of the Nutlin series of MDM2-p53 inhibitors. He has directed numerous initiatives including fragment-based lead discovery and the building of PPI-targeted screening libraries. David has co-authored over 50 publications.
Seungyong Sean Choi, Ph.D. – Vice President, Process R&D, Chemistry
Sean Choi joined NJ Bio, Inc. as the Head, Process R&D Chemistry in October 2021 and currently serves as Vice President of Process R&D, Chemistry. He has over 25 years of experience in planning and managing research activities of CROs and leading research teams in the rapid process development of payload-linker chemistry, biologically active cytotoxins for final target synthesis, and technical transfer to a kg-lab and pilot plant scale (cGMP). He successfully led drug discovery programs for clients and developed multiple commercialized products. Sean is also co-author in over 30 peer-reviewed journals and patents. Prior to joining NJ Biopharmaceuticals, he worked as the Director of Chemistry of Abzena and as Principal Scientist at The Chemistry Research Solution (TCRS), where he focused on the design and synthesis of payloads, linkers, and High-Potent APIs in ADCs to support clinical trials and cGMP projects. Prior to TCRS, he held a variety of leadership roles in extensive hands-on medicinal chemistry programs and manufactured small molecule Active Pharmaceutical Ingredients (APIs) at New England Drug Discovery Partner and PharmaCore (currently, Cambrex in NC). Sean received his Ph.D. from Wayne State University in 1994 with Professor M. E. Newcomb, after which Sean joined the team of Nobel Laurate in Chemistry, the late Professor Sir Derek H.R. Barton of Texas A&M University as a post-doctoral research fellow.
Bhaskar Kusuma, Ph.D. – Vice President, Analytical R&D
Bhaskar Kusuma joined NJ Bio, Inc. as Principal Scientist in Analytical Development and is currently Vice President, Analytical R&D. Bhaskar has over 10 years of extensive experience in the field of analytical method development, method optimization, and phase appropriate method validation for characterization of small molecules, peptides, proteins, oligonucleotides, antibodies, and Antibody Drug Conjugates (ADCs). Before joining NJ Bio, Bhaskar worked in the Analytical Method Development group at SciGen Pharmaceuticals, Amneal Pharmaceuticals, and Ajinomoto Biopharmaceuticals. He obtained his Ph.D. in Organic Chemistry from the Indian Institute of Chemical Technology on the development of novel synthetic methodologies and formal synthetic methodologies and formal total synthesis of bafilomycin A1. After his Ph.D., Bhaskar was a post-doctoral fellow at University of British Columbia & University of Kansas in medicinal chemistry. At Kansas University, he worked on design, synthesis, and biological evaluation of HSP90 inhibitors to target multiple cancer, and developed a novel HSP90 c-terminal inhibitor as a potential candidate for treating Alzheimer’s and Parkinson disease; currently this molecule is in Phase 2 clinical.
Anil Eapen – Vice President of Manufacturing
Anil Eapen joined NJ Bio in July 2023 as the Vice President of Manufacturing, bringing 20 years of experience to the company. Previously, Anil held leadership roles at various pharmaceutical and biotechnology companies, managing manufacturing and supply chain operations for multiple products at various stages of drug development. Most recently, Anil was Senior Director in Technical Operations, overseeing all manufacturing and supply chain activities at Gennao Bio, Inc. He oversaw the process development and manufacturing of a new and unique antibody and helped support the ADC workstreams. Prior to Gennao Bio, Anil served as the Director of External Manufacturing and Supply Chain for Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company focusing on gene therapies. Before joining Prevail, he was a Director of Manufacturing and Supply Chain at Advaxis, Inc., an immunotherapy company. Anil held various roles at Advaxis and oversaw the buildout of the company’s internal manufacturing capabilities. Anil began his career as a shop floor Manufacturing Supervisor at Wyeth (now Pfizer), supporting the production of Prevnar® and Prevnar 13®. Anil graduated with a B.S. in Chemical Engineering from Rutgers University and an M.S. in Chemical Engineering from New Jersey Institute of Technology. He’s currently completing his Doctorate in Engineering at George Washington University.
Joe Ponte, Ph.D. – Executive Director of Research and Development
Arpit Pokharna, ACA, CS – Executive Director and Chief Financial Officer
Arpit Pokharna is the Executive Director and Chief Financial Officer (CFO) at NJBIO India. He oversees and provides support to NJBIO India’s financial and administrative operations. Arpit has more than seven years of experience as a finance professional with diversified global exposure in industries including Downstream Petrochemicals & Construction Chemicals and Banking and Financial Services. He obtained his bachelor’s degree in business management from Narsee Monjee College of Commerce & Economics, Mumbai. He is certified as a Chartered Accountant (ICAI), Company Secretary (ICSI) and holds a post-graduation certification in finance from the Indian Institute of Management, Indore (IIM-I).
Thomas Markotan, M.S. – Head of EHS
Tom joined NJ Bio’s chemistry team as a Senior Research Fellow and is currently the Head of EHS. He is an organic chemist with twenty-five years of industrial research experience as well as several years of academic research experience.
Tom is an expert in planning and conducting multi-step organic syntheses and had spent eleven years working on the design and synthesis of payload-linkers for ADCs, one of which is currently advancing into clinical trials.
Prior to joining NJ Bio, Tom held R&D positions with Abzena and The Chemistry Research Solution (TCRS) as Associate Director of Chemistry and Principal Scientist, respectively, after working many years for Johnson & Johnson Pharmaceutical R&D and 3-Dimensional Pharmaceuticals, where he was part of a team that put two potent, orally active thrombin (FIIa) inhibitors into clinical trials. Tom earned an M.S. degree in Organic Chemistry at the University of Pittsburgh and is a co-inventor on 44 U.S. and World patents and co-author of nine peer-reviewed journal publications.
Board of Directors
Ronald Gold began his generic pharmaceutical career in 1988 as a sales representative for quality companies such as Par Pharmaceuticals, Hi-Tech Pharmacal, Invamed Labs and others. In 1992, he founded Rising Pharmaceuticals as President and CEO, where he quarterbacked all aspects of the business, including sales and marketing, product development, accounting, budgets, government rebates, regulatory and other functions. In 2010, he oversaw the sale of Rising to Aceto Corporation (ACET), continuing as President and COO of Rising for two and a half years before exiting and starting Leading Pharma. He is currently CEO and Chairman of the Board of Leading Pharma.
Steven M. Klosk
Steven Klosk has spent over 25 years in the pharmaceutical CDMO industry. Most recently, Steve was the CEO of Cambrex Corporation for twelve years until he retired in 2020 after leading the sale of Cambrex to Permira, a leading global private equity firm at an enterprise value of $2.5B. Under Steve’s leadership, Cambrex became a leading global, fully integrated supplier of drug substances, drug product and testing services across the entire drug life cycle to both the innovator and generic pharmaceutical markets. Through significant organic investments and M&A Cambrex grew into a network of twelve manufacturing and R&D sites in the USA and Europe with over 2,000 employees. Full year revenues in 2019 were approximately $650M. In addition to serving on the NJ Bio board he is a member of the Board of Directors of Recipharm, a leading European-based pharmaceutical CDMO and Caladrius Biosciences a publicly traded cell therapy drug development biotech company. Steve graduated with a BS degree in Industrial & Labor Relations from Cornell University and a JD from New York Law School.
Chetan Jain is the Founder and CEO of Trichem and Chemistry & Health LLP (C&H). Chetan established Trichem in 1998, as a first-generation entrepreneur. Since then, Trichem has evolved as a differentiated sourcing partner for Active Pharmaceutical Ingredients (APIs) and intermediates for global pharmaceutical companies. Trichem is the flagship company in the portfolio, with 35 Principals spanning Europe and Southeast Asia, and a customer base of over 175 companies for US, EU, and other regulated markets. Chetan’s other business interests include Trichem Health Care Pvt. Limited (distribution arm), Trichem Life Sciences Limited (domestic & ROW manufacturing, and marketing of APIs), and Chemistry & Health LLP (C&H; investments in pharmaceutical start-up companies in the US and India). Chetan has studied Commerce at the University of Mumbai.
Anjanish R. Gondalia
Anjanish is Vice President of Operations of Leading Pharma. He began his career in the pharmaceutical industry working as a business development analyst & product planning at Corepharma for finished dosage products. Later Anjanish went on to join Apicore, where he focused on business development and marketing for APIs for the US & ROW market.
Prior to Leading, Anjanish was Director of Operations at Terrene Pharmaceutical & Director of Operation at a pharmaceutical manufacturing start-up, Kalintis Healthcare. His experience working in formulations and APIs provides a unique and advantageous insight to the pharmaceutical industry.
Anjanish is a Member of the Board of Directors of NJ Biopharmaceuticals LLC d/b/a NJ Bio. In addition, he is also Managing Director & member of Board of Directors for Kalintis Healthcare, an Active Pharmaceutical Ingredient manufacturer focused on the R&D, pilot and commercial development of high-value APIs and Intermediates.
Scientific Advisory Board
Ravi Chari, Ph.D.
Rakesh Dixit, Ph.D., DABT
Jagath Reddy Junutula, Ph.D.
Dr. Junutula is the Co-Founder, President & CEO of Aarvik Therapeutics, Inc., a next-generation ADC company. Prior to founding Aarvik, he was the Senior Vice President, Research & Development at ModMab Therapeutics, Inc. Dr. Junutula has over 15 years of experience in oncology drug discovery and more than 25 years of experience in the life science research as a biochemist/molecular cell biologist. Dr. Junutula supervised and trained researchers in the antibody-based discovery projects. He developed a novel THIOMAB technology platform to obtain engineered Antibody Drug Conjugates with defined number of drugs to improve therapeutic utility. Dr. Junutula contributed and collaborated with several cross-functional teams in discovery research, pre-clinical research, and manufacturing to move antibody based therapeutic molecules from discovery to IND, authored over 100 patents/peer-reviewed publications, and presented work at numerous international conferences. His specialties include Target Discovery in Oncology, Antibody Discovery and Development, ADCs, and Bi-specific antibodies. Jagath serves as an Editorial Board member of mAbs and ACS Med Chem Letters journals and also a recipient of World ADC’s prestigious award for “Long Standing Contributions to the ADC field” in 2017.
Zhihua Sui, Ph.D.
Zhihua Sui, Ph.D. has >30 years of experience in drug discovery and development. He is currently Chief Scientific Officer and Head of Preclinical Research and Development at SK Life Science Labs. Before joining SK Life Science Labs, Zhihua was the CSO, Head of Research & Preclinical Development at Proteovant Therapeutics, a biotech company dedicated to harnessing physiological protein homeostasis to degrade the most difficult to ligand/drug proteins. Zhihua was the VP Head of Chemistry (2013-2021) at Agios Pharmaceuticals and Sr. Sci. Dir./Sr. Dir. of drug discovery in various therapeutics areas at Janssen Pharmaceutical Companies of Johnson & Johnson (1993-2013). He did postdoctoral research in structural based drug designs (SBDD) & Biochemistry at UCSF and received PhD in Organic Synthesis at Heidelberg University in Germany. Zhihua obtained MS/BS in Medicinal Chemistry and did medical school in China. Over the years, his teams have advanced >20 compounds into the clinical development across various therapeutic areas including oncology, metabolic diseases, immunology, women’s health, men’s health, and rare genetic diseases. Zhihua has more than 300 scientific publications in peer-reviewed journals and patent literature as well as invited lectures.