Manufacturing Capabilities – Welcome to Nivagen Pharmaceuticals

Jay Roderick - Head of Manufacturing, Sterile Operations

Jay Roderick is a seasoned biopharmaceutical executive with over 20 years of progressive leadership experience. His career has spanned Nuclear Power, Industrial Gas, Food, and Biopharmaceuticals, including sterile manufacturing, operations, technical sourcing, and organizational transformation. He has held key leadership roles at globally recognized companies including Dendreon, Takeda, Lonza Biologics, CCRM, Thermo Fisher Scientific, and currently serves as Head of Manufacturing, Sterile Operations at Nivagen Pharmaceuticals.

Known for his strategic mindset and people-first leadership style, Jay has built and led high-performing teams across both clinical and commercial manufacturing environments. His experience includes launching greenfield facilities, navigating complex regulatory landscapes, and driving operational excellence in both cell therapy and traditional sterile injectable platforms.

Throughout his career, Jay has led critical initiatives across North America—from scaling personalized immunotherapy operations at Dendreon, to advancing biologics production at Lonza, to shaping global technical sourcing strategy at Thermo Fisher. He brings deep cross-functional expertise with a consistent focus on execution, compliance, and building resilient, mission-driven teams.

Jay holds a background in Nuclear Engineering & Business Management and is passionate about cultivating a culture of accountability, innovation, and continuous improvement. His leadership continues to guide organizations through pivotal growth phases while delivering on quality, performance, and long-term value.

Venkatesh Muttepwar

Venkatesh Brings over 26 years of experience as a seasoned expert in strategic planning, design, construction, and facilities operations across healthcare, pharmaceutical, and FMCG industries. He has held senior management roles in engineering and construction for major pharmaceutical manufacturers, including Teva (formerly Watson), Cipla Ltd, Piramal Pharma, Dr. Reddy’s, and Mondelez (formerly Cadbury).

Mechanical Engineer with extensive experience in sterile facility design, Venkatesh is renowned for his expertise in state-of-the-art sterile isolator technology. His extensive work spans the design, build, and operation of sterile facilities across the USA, UK, and India. Venkatesh’s earlier experience evolved around building the facility for aseptic, oral solid dosage (OSD), ointment, soft gel capsule, and high-potent sterile and OSD manufacturing facilities with a major Focus on operational efficiency, cost-effectiveness, innovation, and long-term sustainability in project execution.

Dr. Nirav Patel

A seasoned pharmaceutical executive with over two decades of pharmaceutical and healthcare industry experience, Dr Patel brings a wealth of expertise to Nivagen. With an unwavering focus on scientific excellence and strategic innovation, he drives the development of groundbreaking solutions. Dr. Patel’s expertise in process development, regulatory strategy, and team building is instrumental in translating complex scientific concepts into tangible, market-ready products.

Prior to joining Nivagen, Dr Nirav held key roles at leading pharmaceutical companies including Amneal, Ingenus, Jubilant, Baxter, Symbiotec and Dorizoe. His impressive track record includes the successful launch of multiple complex branded (505(b)2) and generic (ANDA) injectables and ophthalmic formulations, demonstrating a deep understanding of the regulatory landscape and patient needs. As a visionary leader, Dr. Patel fosters a culture of innovation, inspiring his team to achieve unprecedented heights in drug development.

Holding advanced doctorate degrees in pharmaceutical science, Dr Patel is a strategic thinker with a strong scientific focus. He has authored numerous journal articles and holds several patents in formulation development. His strategic acumen, coupled with a strong operational focus, positions Nivagen at the forefront of pharmaceutical advancements.

Andrea Felix

Andrea Felix brings over 25 years of pharmaceutical sales expertise to the Nivagen team. After three years of working as a Registered Nurse for UCLA Medical Center, she joined Fougera Pharmaceuticals in 1994 as a sales representative calling on independent pharmacies and hospitals. Four years later she was promoted to National Account Executive calling on small to mid-size retailers and distributors, and in 1998 she was promoted to National Account Director calling on large retailers and wholesalers and where she spent 13 years. In 2007 she joined Perrigo Pharmaceuticals as Director – National Accounts, working there for 11 years. Andrea is knowledgeable in all aspects of the business, from generics, branded, and OTCs, new product set up and sales tracking, to customer-facing product launches and contract negotiations. Her medical background coupled with the fact that her father worked in the wholesale industry for 40 years made pharmaceutical sales a perfect fit for Andrea.

Tom Henry

Tom Henry brings over 24 years of pharmaceutical sales expertise to the Nivagen team. Upon graduation from Emory University, he launched his career at Goldline Laboratories. After 7 years selling generic products for a full line re-packager, he saw the shift to manufacturers distributing under their own label. For the next 17 years he covered the Western US for ETHEX Corporation. He then consulted for both branded and generic companies before joining Nivagen Pharmaceuticals, Inc. in 2014. Tom is knowledgeable in all aspects of the business, from behind-the-scenes new product set up and sales tracking, to customer-facing product launches and contract negotiations. It’s no surprise that Tom Henry ended up in pharmaceutical sales – with a McKesson sales rep father, he practically grew up in the drug industry!

Dr. Dasaradhi Lakkaraju, PhD

Dr. Das got his Ph.D from Osmania university and did his Postdoctoral fellowship in the Department of Chemistry at University of Durham in England, New Mexico State University, and at the Department of Pharmacology in State University of New York, Stony Brook. Dr. Das brings a tremendous amount of knowledge that was built over 24 years of analytical chemistry experience in the pharmaceutical industry. He has experience in solid orals, both extended release and immediate release tablets, and capsule formulations including controlled substances, as well as parenteral: lyophilized products and liquids, oil based depot formulations, suspensions, peptides, steroids and oncology products, ophthalmic: liquids and suspensions. He has lead intellectual property development projects using reverse engineering techniques and circumventing patents for Paragraph-IV filings. He has contributed significantly to several ANDAS, NDAs and 505(b)(2)s. He has published 24 papers in peer reviewed Journals and also has patents in formulation development.

Robert Miller

Robert Miller brings a great depth of financial expertise to Nivagen. He served as Chief Financial Officer at Sonoma Pharmaceuticals for 14 years. Bob’s extensive experience includes CFO positions at: GAF Corporation, Penwest Co., Ameron Corp., and Bugle Boy. He also served as Treasurer of Mead Corporation, and as Vice President of investment banking at Blyth, Eastman Dillon & Co. Bob cut his teeth as an analyst in investment banking at Merrill Lynch. Bob graduated from Stanford University with a BA in Economics, and holds an MBA from Columbia University in Finance. He also served in U.S. Marine Corps as a captain, where he received a Purple Heart.

Jay Shukla - RPh, MBA

As a registered pharmacist with an MBA in pharmaceutical management, and over 20 years of diverse experience both in Asia and the USA, Jay brings expertise from both sides of the world. He specializes in business development, corporate strategy, sourcing and international business. Jay acquired more than 4 years of Indian pharmaceutical industry experience where he worked at different levels of supply chains: starting as a sales representative, and going up to product manager, and everything in between. Jay has worked in the US pharmaceutical industry for more than 16 years, again starting as pharmacist behind the counter, and then moving on to sourcing manager, and policy advisor to the largest state run Medicaid program in the US. Jay holds a B.S. in pharmacy from K.L.E.’s College of Pharmacy, Banglore, India, and an MBA in Pharmaceutical Studies from Silberman College of Business, Madison, New Jersey.