NJ Biopharmaceuticals LLC is a CRO/CDMO that provides integrated chemistry and biology services to clients from the biotech and pharma sectors. Main service areas include multistep organic synthesis, medicinal chemistry, bioconjugation, antibody-drug conjugates, and flow chemistry. The company is headquartered in the Commercialization Center for Innovative Technologies (CCIT) in North Brunswick, NJ, with additional chemistry facilities in Bristol, PA, and a satellite office in Cambridge, MA. NJ Biopharmaceuticals has exclusive partners in India for flow chemistry services as well as chemical process R&D and cGMP manufacturing.
NJ Biopharmaceuticals has a strong background in synthetic organic chemistry and protein-based biopharmaceuticals and is an integrated service provider with expertise in the following areas:
- Antibody-drug conjugates (ADCs), bioconjugation to proteins and biomaterials, linker chemistry design for conjugations, ADC constructs, and process development for small molecules and ADCs.
- Multi-step customized flow chemistry synthetic routes for drug intermediates and APIs in collaboration with Amar Chemistry Pvt. Ltd., along with a unique offering to design custom flow chemistry equipment in collaboration with experts at Amar Equipment Pvt. Ltd.
- Medicinal chemistry from lead generation via lead optimization to scale-up, with the option of engage into blended FTE services with Indian partner companies.
- Manufacture of research-grade proteins and antibodies.
- Development of plate-based assays to evaluate the ability of compounds to promote or inhibit cell proliferation.
Our mission is to provide value-added chemistry and biopharmaceutical services to enable our clients to accelerate their product development programs and build long-lasting collaborative relationships. Our goal is to provide value through efficient, timely, and cost-effective solutions that meet our clients’ needs. NJ Biopharmaceuticals embraces the standards of teamwork, confidentiality, and reliability with innovative solutions to our clients’ most challenging research requirements. Customer satisfaction is our highest priority.
OUR PEOPLE AND CULTURE
We have highly talented and experienced laboratory chemists and biologists with a tremendous passion for chemistry and biology resulting in unique solutions to client programs. Furthermore, our corporate culture is collaborative, communicative, and adaptable. Most importantly, our scientists strive to deliver quality services in a cost-effective and timely manner.
President & CEO: Nareshkumar Jain, Ph.D.
Dr. Jain is the founder and CEO of NJ Biopharmaceuticals LLC and co-founder of Amar Chemistry Pvt. Ltd. He is also a member of Robin Hood Ventures, a leading Mid-Atlantic investment group. Prior to founding NJ Biopharmaceuticals in 2018, Dr. Jain served as Global Head of Chemistry and Senior Vice-President of ADC Biomanufacturing at Abzena. In 2009, Dr. Jain 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. Dr. Jain has more than 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 more than 60 publications, patents, and chapters in medicinal/synthetic chemistry books. Among his notable achievements are the total syntheses of complex natural products including the antibiotics vancomycin and rutamycin. Dr. Jain 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. Dr. Jain got extensive leadership training through the Advanced Management Program of The Wharton School of The University of Pennsylvania.
Executive Senior Director of Business Management: Ralf Mueller, Ph.D.
Dr. Mueller joined NJ Biopharmaceuticals as Executive Senior Director of Business Management and his responsibilities include the company’s business development, proposal management, and marketing activities. Dr. Mueller has almost twenty years of experience working for chemistry and biopharmaceutical CROs and CDMOs, covering the fields of business development, custom synthesis, process development and GMP manufacturing. His previous positions include 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. Dr. Mueller received his Ph.D. 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 antiproliferative polyamine analogues. He has co-authored 15 research articles on potential drugs against cancer and dyslipidemia.
Director of Chemistry and Flow Sciences: Bram Karsten, Ph.D.
Dr. Karsten received his Ph.D. in organic chemistry in 2010 from Eindhoven University of Technology, where he investigated the synthesis of π-conjugated small molecules and polymers for organic solar cell applications. He performed postdoctoral research at MIT in the group of Prof. Stephen L. Buchwald, focusing on the multistep flow synthesis of pharmaceuticals. Outside of academia, Dr. Karsten has held several research positions at small companies, focusing on complex synthetic chemistry for functional materials. Dr. Karsten’s work has been published in 11 journal articles and one patent.
Senior Research Fellow – Chemistry: Tom Markotan, M.S.
Tom joined NJ Biopharmaceuticals’ chemistry team as Senior Research Fellow. He is an organic chemist with over twenty 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 on milligram- to multi-gram scales and has spent the last eight 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 Biopharmaceuticals, Tom held R&D positions with Abzena and The Chemistry Research Solution LLC (TCRS) as Associate Director of Chemistry and Senior Scientist, respectively, as well as with Johnson & Johnson Pharmaceuticals R&D and 3D Pharmaceuticals, Inc., where he was part of a team that progressed two potent, orally active thrombin (FIIa) inhibitors into clinical trials. Tom’s work at TCRS contributed significantly to the success of the company. Tom received his M.S. degree in Organic Chemistry from the University of Pittsburgh and is a co-inventor on 37 U.S. and World patents and a co-author in seven peer-reviewed journal publications.
Principal Scientist and Head of Biology: Irina Bruck, Ph.D.
Dr. Bruck is a leading protein biochemist with extensive experience in protein characterization, protein chemistry, protein isolation and purification, protein enzymology, and immunology. Dr. Bruck was the first to purify and characterize the UmuD’C polymerase while earning her doctoral degree in the lab of Dr. Myron Goodman at the University of Southern California. After her Ph.D., Dr. Bruck pursued postdoctoral studies as a Howard Hughes Scholar at Rockefeller University in the lab of Prof. Michael E. O’Donnell, a member of the National Academy of Sciences. While at Rockefeller, Dr. Bruck was the first to purify intact recombinant protein machinery, composed of more than a dozen molecular subunits, for the replication of DNA from five different Gram-positive bacteria. Dr. Bruck then worked as a Research Professor at Vanderbilt University and Florida State University, where she studied the reconstitution of the eukaryotic replication initiation apparatus using recombinant methods of over 20 budding yeast protein subunits. Dr. Bruck discovered that Sld3/Treslin, a replication initiation protein, stimulates kinase phosphorylation and activation of the replication helicase assembly in eukaryotes. Dr. Bruck has published 30 manuscripts and received twelve patents. After pursuing additional studies in immunology at Columbia University College of Medicine, Dr. Bruck joined NJ Biopharmaceuticals as Principal Scientist and Head of Biology in early 2019.
Head of the General Administration and Finance: Poonam Amrute
Poonam joined NJ Biopharmaceuticals LLC as Manager of Finance and General Administration. She ensures smooth functioning of general operations while providing administrative support, accounting, financial reporting, human resources, logistics and communications. Poonam is the first point of contact for the company and functions as the right arm to the President & CEO of the company. She has diverse experience working for organizations across multiple industries. Poonam earned her Master’s degree in Accounting and Economics from Pune University, India.
Distinguished Research Leader: David Fry, Ph.D.
Dr. Fry joined NJ Biopharmaceuticals as Distinguished Research Leader in early 2019. Dr. Fry 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 Biopharmaceuticals, he served for three years as Vice-President of Protein Chemistry at The Chemistry Research Solution LLC. Dr. Fry has 27 years of drug discovery experience as Head of Structural Chemistry at Hoffmann-La Roche. He is a globally recognized expert in the use of NMR to discover small molecule drugs for protein-protein interaction (PPI) targets. His 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 which are currently in clinical trials. Dr. Fry has directed numerous initiatives including fragment-based lead discovery and the building of PPI-targeted screening libraries. Dr. Fry has co-authored over 50 publications.
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.
Ajanish is a Member of the Board of Directors of NJ Biopharmaceuticals LLC. 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
Zhihua Sui, Ph.D.
Zhihua is an experienced drug hunter and a leader in drug discovery in both big pharma and biotech. He is currently VP, Head of Chemistry at Agios Pharmaceuticals in Cambridge, MA. Before joining Agios, Zhihua spent a couple decades at Janssen Pharmaceutical R&D of Johnson & Johnson, rose through the scientific and management ranks to Sr. Scientific Director/Janssen Fellow and led various medicinal chemistry teams as well as platform chemistry. Over the years, Zhihua’s teams advanced more than 20 compounds into clinical stage for treatment of cancer, rare genetic diseases, reproductive disorders (men’s and women’s health), inflammation and diabetes. Zhihua has extensive experience in drug discovery platforms such as SBDD, FBDD and mechanism-based designs and protein degradation. Zhihua is a co-author or co-inventor on more than 300 publications in peer-reviewed journals, invited lectures and patents. Zhihua is experienced in diligence of external assets and in outsourcing management. Zhihua did postdoctoral research at UCSF, received Ph.D. from Heidelberg University in Germany and MS/BS in China.