Darren Head is Chief Executive Officer of Bionova Scientific. He also served as Chairman of Bionova’s Board of Directors from 2019 until the company was acquired by Asahi Kasei in 2022. Darren also serves as Chairman of the Board of Cellipont Bioservices, a cell therapy CDMO based in the San Diego area.
Prior to joining Bionova, Darren was CEO of MaSTherCell, a global CDMO specializing in cell and gene therapy products. He steered MaSTherCell through a period of rapid growth leading to its acquisition by Catalent in 2020.
Prior to MaSTherCell, Darren spent nearly 10 years as President and CEO at Cytovance Biologics, which he successfully built into a premier biologics CDMO, culminating in its acquisition by Hepalink USA in 2015.
Darren joined Cytovance after nearly 20 years of biologics operations leadership experience. At Immucor, he served as vice-president of worldwide operations, overseeing the manufacturing of biological products in the US, Europe, and Canada. Darren also served as operations manager and project manager for companies such as Aronex Pharmaceuticals (The Woodlands, TX), Allergan Optical (Waco, TX), and Abbott Laboratories (Rocky Mount, NC).
Mr. Head holds a B.S. in biology and attended the executive M.B.A. program at Texas A&M. Additionally, he served in the United States Air Force during Operation Desert Storm.
Amy Kong is Chief Scientific Officer and Co-Founder of Bionova Scientific, where she has led the company through rapid growth and expansion from its early days as a start-up CRO to its current state as a full-service CDMO.
Prior to co-founding Bionova in 2014, Amy held several scientific roles at leading biopharmaceutical firms including Boehringer Ingelheim, Amgen and Abgenix. At Boehringer Ingelheim, Inc. and Amgen, Amy spent several years as a Senior Research Scientist where her responsibilities included managing the Upstream Process Development group, leading media development activities, process development and process characterization (including characterizing the production bioreactor unit operation for a commercial process), process transfer and process improvements. In these roles, Amy prepared cell culture filings for the FDA QbD pilot program. She also evaluated the impact of critical raw materials on the productivity and product quality for a commercial process, resulting in 30% improvement in titer and improved process consistency.
In a prior role at Abgenix, Amy specialized in commercial cell line development and vector performance improvement. She successfully developed high producing cell lines for production and an IND filing using a DHFR-amplified system and also worked intensively with several CHO host cell lines, including CHO-DG44, DUXB-11, and CHO-K1. At Abgenix, Amy also developed protein expression vectors and evaluated them through small scale cell culture. She successfully improved vector performance by optimizing the promoter, introns and other vector enhancing elements.
She started her career as a molecular biologist at Scios, Inc., where she focused on vector constructs, gene expression and cloning.
Amy has published several peer-reviewed scientific articles and is the inventor of record for a U.S. patent involving mediators of signal transduction.
Amy earned her M.S. in Chemistry at the University of Minnesota and her B.S. in Biology at Fudan University, Shanghai, China.
Chung Chun is Chief Technology Officer and Co-Founder of Bionova Scientific.
Prior to co-founding Bionova in 2014, Chung spent nearly 20 years in the biopharmaceutical industry, establishing an impressive track-record of delivering technical results and achieving business goals. Much of her pre-Bionova career was at Abgenix, Amgen and Boehringer Ingelheim.
Most recently, Chung was a Senior Manager at Boehringer Ingelheim overseeing process development, tech transfer, and GMP campaigns for BI’s CDMO operations.
During her prior tenure at Abgenix (and later as part of Amgen), she was instrumental in the development and production of Vectibix®. For 10 years, she shepherded the product from the R&D stage, through IND and BLA filings, and into commercial GMP production.
Chung’s technical experience and expertise focuses on clinical and commercial upstream process development, process characterization; cGMP facility design and buildout including stainless steel and single-use technologies; manufacturing operations including Tox, Phase I, II, III and commercial; clinical and regulatory affairs including IND & BLA filings; and commercial product audits including FDA, EMEA, KFDA, ANVISA, PMDA & CFIA.
Chung earned her B.A. in Molecular and Cell Biology at the University of California, Berkeley.
Richard Vaillant has over 30 years of experience in the pharmaceutical and medical device sectors in the life sciences industry.
Prior to joining Bionova Scientific as Chief Financial Officer, Rich served as Director of Portfolio Company Financial Operations of Great Point Partners. Prior to Joining Great Point Partners he served as Chief Financial Officer of Vitalink Research, a Clinical Trial Services site management organization a former GPP II portfolio company.
Prior to Vitalink Research Mr. Vaillant served as the Chief Financial Officer of Cytovance Biologics (CDMO), a former GPP I portfolio company (7.4x return on invested capital). During his tenure at Cytovance (2011 -2016), revenues grew at a 45% CAGR. In prior roles, Rich served as Chief Financial Officer of Histogenics Corporation a tissue regeneration company and as Corporate Operations Controller of American Cystoscope Makers, Inc., a Urology, Endoscopy and Gynecology medical device manufacturing company. Previously, he spent over a decade at Boston Scientific Corporation, a multi-billion-dollar medical device manufacturer as Division Controller for two divisions (Meditech and Meadox).
Rich earned a B.S. in Accounting from Merrimack College and an M.S. in Accounting from Suffolk University.
Jim Andrews is Vice President of Facilities and Engineering at Bionova Scientific, with responsibility for maintaining and expanding facility and infrastructure capabilities in support of cGMP, Development, and Analytical activities.
Jim has over 30 years of experience in the pharmaceutical and drug/device sectors, with leadership roles at divisions of Novartis, Johnson & Johnson, and BASF. Within each of these organizations, Jim operated as a Subject Matter Expert for Engineering and Validation in regulatory and partner audits. Jim’s engineering roles have included responsibility for Facility & Equipment Design, Engineering, Construction, Maintenance, and Calibration, Sustaining Operations, Site Master Planning, Sterility Assurance, Shutdown Planning and Execution, and Environmental, Health & Safety.
Additionally, Jim has had roles within the Manufacturing Science & Technology and Quality Assurance organizations at these sites, leading cross functional teams in Commissioning, Qualification, and Validation of engineered systems and new product introduction and scale-up activities.
Leading up to joining Bionova, Jim worked as a Senior Project Manager for a well-established Architectural & Engineering firm in the Bay Area. His project portfolio there included leading design efforts at several large Biotechnology companies within their Manufacturing and Laboratory areas.
Jim earned his B.S. in Chemical Engineering from Bucknell University and an M.B.A from the University of Pennsylvania, Wharton School of Business.
Amy Driver is Vice President of Business Development at Bionova Scientific.
Prior to joining Bionova’s Business Development team, Amy held various marketing and business development posts at Advanced Bioscience Laboratories, Inc. (ABL), with a focus on pre-clinical and clinical CRO/CDMO programs. Most recently, Amy was Technical Sales Manager leading new client acquisition, proposal development, contract review and negotiation and key account management. She also acted as a liaison with ABL’s marketing team to ensure technical capabilities were effectively communicated.
Amy has also held leadership positions at several Washington, DC area non-profit organizations.
Amy holds her B.S. in Chemistry and Biochemistry from the College of Charleston, her M.S. in Toxicology from the School of Medicine at the University of North Carolina, Chapel Hill, and her M.B.A. from the University of Southern California.
Eric Fulmer is Vice President of Quality & Compliance at Bionova Scientific, with responsibility for all quality and compliance programs and systems.
Prior to joining Bionova, Eric held several Quality leadership roles at Samsung Biologics. In his most recent role at Samsung, Eric was Director/Team Leader for Drug Substance Quality Assurance for Samsung’s Commercial and Clinical Manufacturing plants. His responsibilities included Manufacturing Oversight, Batch Review, Warehouse Operations, Raw Material Receipt and Dispensing, Quality Control Laboratories, Investigations, CAPA, Change Control, Product Change Over and more.
Prior to Samsung, Eric held various Quality Assurance roles at Amgen, providing oversight to Cell Banking, Biosafety Laboratories, Analytical Development, Quality Control Testing, Device Design, Drug Substance Manufacturing, Drug Product Manufacturing, Combination Device Assembly, and Packaging / Labeling / Distribution. At Amgen, Eric also managed a manufacturing team performing mammalian cell culture and microbial fermentation to supply clinical studies. Earlier in his career, he worked in manufacturing and pilot-scale process development at Pyramid Biological Corporation, a maker of devices made from human-sourced materials.
Eric holds a B.S. in Chemistry from the University of Utah.
Amy He is Vice President of Process Development at Bionova Scientific.
Prior to joining Bionova, Amy spent 10 years at Abbvie/Abbott Labs as a Principal Research Scientist. She also held scientist roles at Facet Biotech, Protein Design Labs (PDL) Pharma, Affymetrix, Abgenix and Chiron Corporation.
Amy’s early work focused on Target Discovery and Target Validation for drug discovery. Over the past several years, she has focused on developing high-yield production cell lines in NS0 and CHO host cells for GMP manufacturing of clinical and commercial biologics, including mAbs, bi-specific mAbs and non-mAbs proteins. She established best practices to shorten the timeline and reduce labor by evaluating, developing and incorporating new technologies including vector optimization, Octet and AlphaLISA for HT quantitation, Fed-batch Spin Tube/shake flask assay, CloneSelect Imager, ClonePix and FACS sorting. She is an inventor on the US patent for “Vectors and Host Cells Comprising A Modified SV40 Promoter for Protein Expression”.
Amy was also responsible for genetic characterization of cell lines and is highly proficient in identifying and characterizing complex RNA variants to ensure acceptable product quality. She authored and reviewed technical reports and relevant sections in regulatory filing documents for 10 INDs and 2 BLAs.
Amy earned her M.S. in Biochemistry and Biophysics at Iowa State University and her B.S.in Biochemistry at Peking University, China.
Manufacturing, Facilities and Engineering
Hung Huynh is Vice President of Manufacturing, Facilities and Engineering at Bionova Scientific.
Hung joined Bionova Scientific in 2015 as Director of Operations and was instrumental in building our Research and Process Development teams.
Prior to joining Bionova, Hung was Manufacturing Supervisor at Boehringer Ingelheim where he managed a GMP Upstream Manufacturing team and performed more than 10 successful GMP campaigns. He previously held several roles at Amgen, primarily in upstream process development. His work included equipment and process validation for commercialization of Vectibix® and he executed the PC studies and QbD studies for filings.
At Amgen, he was also involved in GMP facility design and led facility fit analysis for upstream tech transfer projects including 15 kL scale GMP production campaigns. He also worked on upstream process development at lab scale in 3L bioreactors and Pilot plant up to 100L tech transfers, and supported troubleshooting on GMP runs including Panitumumab (Vectibix®), Etanercept (Enbrel®), and Denosumab (Prolia®). Hung started his career in cell line development and research material generation projects at Abgenix.
Ling-Ling Kang is Vice President of Protein Sciences (Downstream, Formulation & Analytical Sciences) at Bionova Scientific and oversees the technical sectors in Bionova’s analytical, downstream and formulation groups.
Ling-Ling is an accomplished protein scientist with over 30 years of experience in the biotechnology industry. She brings an extensive chemistry-based understanding to the development of protein therapeutics, protein purification processes, product quality assessment, and formulation stabilization strategies.
Prior to joining Bionova, Ling-Ling held technical positions at Applied Viromics, DURECT Corporation, iMEDD, Inc., Alza Corporation, and Scios, Inc.
Her areas of research have included elucidation of protein structure and biological function relation, peptide synthesis, E. Coli protein expression, and multi-discipline protein reactions and analyses.
Lingling earned her M.S. in Organic Chemistry at the University of Massachusetts at Amherst and her B.S. in Chemistry at National Chung-Hsin University in Taiwan.
Sandhya Khurana is Vice President, Program Management at Bionova Scientific.
Sandhya has 25 years of pharmaceutical and biotechnology industry experience at companies including LifeScan (a J&J company), Abgenix, Amgen, Boehringer-Ingelheim, Abbvie-Stemcentrx, Dermira, Omniox, and most recently at Revance Therapeutics. Sandhya’s responsibilities have included program management, regulatory submissions (IND to BLA), PAI readiness, Quality Systems, product launch, portfolio management, budget oversight, and merger/acquisition/integration activities. In addition, she has managed relationships with customers, CDMOs, corporate alliances, and strategic partnerships.
Sandhya earned her B. A. in Molecular and Cell Biology from the University of California, Berkeley, and M.B.A. from Santa Clara University. She is also a Lean Six Sigma Black Belt and board member of the East Bay Chapter of the Association for Women in Science.
Brad Larson is Vice President of Corporate Planning/Strategy at Bionova Scientific.
Prior to joining Bionova, Brad spent over six years with Samsung Biologics in Incheon, South Korea. During his tenure with Samsung, Brad held leadership roles in project management, sales and business development, leading cross-functional teams, building tools/systems and consulting directly with clients from kick-off to commercial production. At Samsung, Brad successfully reduced average project timelines by 75% and improved customer satisfaction. He also instituted and led routine deviation review boards to improve deviation management and quality. He advised and guided clients and internal departments in preparation for first Pre-Approval Inspections (PAI) and follow-up regulatory inspections and responses. Brad has regularly interacted with all major global regulatory agencies throughout his career in both the US and South Korea.
Before joining Samsung Biologics, Brad spent 22+ years with Jubilant HollisterStier (formerly Bayer Corporation then Hollister-Stier) a global CDMO. At Jubilant HollisterStier, Brad held senior leadership roles of increasing responsibilities in Manufacturing, Logistics and Project Management. He was responsible for building or leading teams, departments, and aseptic manufacturing facilities to support Jubilant’s North American Aseptic Manufacturing and Operations.
Brad earned his B.S. in Botany at Oregon State University in Corvallis, Oregon.
Chantay Erickson is Senior Director of Supply Chain at Bionova Scientific where she oversees all Logistics and Supply Chain activities
Chantay has 30 years of experience in the biopharmaceutical and pharmaceutical industry. Prior to joining Bionova, Chantay was Vice President – Global Supply Chain at KBI Biopharma where she consolidated supply chain and procurement activities across five production sites in the US and EU to create a Global Supply Chain and Procurement unit. Chantay has held various supply chain and project management roles at Ardelyx, Boehringer Ingelheim (BI), Amgen and Genentech. Chantay’s Supply Chain roles have included Materials Planning, ERP System Implementation, Master Scheduling, Capacity and Resource Planning, Clinical Supply Chain Management, Project Life Cycle Management, External CDMO Management and Commercial Supply and Distribution Management.
Chantay holds her B.S. in Business Administration from Embry Riddle Aeronautical University in Arizona, and APICS Certifications.
Analytical Science and Formulation Development
Li Zhang is Senior Director of Analytical Science and Formulation Development at Bionova Scientific.
Li has over 25 years of pharmaceutical and biotechnology industry experience at companies including Cell Genesis, Abgenix, Amgen, Biehringer-Ingelheim, LakePharma, Anthera, and Coherus. Li has worked in research, Process Development and QC with extensive experience in CMC analytical activities, including analytical method development, transferring, qualification and validation for in-process, release and stability testing for DS, DP and final product, reference standard generation and qualification, specification setting, comparability, and characterization for therapeutic protein drugs. Prior to joining Bionova Scientific, Li was QC product lead for an approved therapeutic drug submission in 2021 at Coherus Biosciences.
Li earned her M.S. in Biochemistry and Molecular Biology from University of California, San Diego and her B.S. in Chemistry from Lanzhou University, China.
Conway Chang is Director of Quality Assurance Validation at Bionova Scientific where he oversees all validation activities.
Prior to joining Bionova, Conway held several Quality positions at Sutro Biopharma, most recently Senior Manager of Quality Systems & Validation / Compliance. Previously, as part of Sutro’s manufacturing team, he assisted with the construction of their new GMP manufacturing facility. In a prior Process Development role at Sutro, Conway helped develop their proprietary cell-free extract process.
Conway also held previous Process Development, Manufacturing and Cell Culture positions at Genentech, Abgenix and Amgen.
Conway earned his B.S. in Microbiology at the University of California, Davis.
Lillian Jiang, M.D. is Director of Project Management at Bionova Scientific where her responsibilities include managing client projects in research material generation, commercial cell line development, upstream and downstream process development, and tech transfer.
Prior to joining Bionova, Lillian gained laboratory and industrial experiences as a scientist at Applied Viromics. She enrolled in the Department of Pharmacology and Toxicology at University of Toronto where she studied mechanism of action of pharmaceuticals, experimental design and data analysis for clinical trials. She participated in Dr. Roger S. McIntyre’s (co-chair of Canadian Network of Mood and Anxiety Treatment Task Force) research team on characterizing association between mood disorders, cognitive function and medical comorbidity.
Lillian received her medical degree in clinical medicine from Harbin Medical University at Harbin, China and was a clinical physician in cardiology. She earned her B.S. with Distinction in the Pharmacology and Toxicology Specialist Program at the University of Toronto, St. George Campus.
Youjin Kim is Director of Downstream Process Development at Bionova Scientific.
Prior to joining Bionova, Youjin was in the engineering group at Samsung Biologics where she sup-ported the overall facility design of a new 12X15KL bioreactor facility and led overall procurement, design, construction and validation activities to implement 30 stainless steel bioreactors and 9 ATF systems.
She also led group efforts to qualify single use vendors by performing technical audits. Before Sam-sung, Youjin led various upstream process development projects at Boehringer Ingelheim, including scale-up/scale-down studies from 2L to 12KL and equipment modifications to accommodate different operation modes for bioreactors.
Youjin started her career in MedImmune’s manufacturing team, where she supported tech transfer of an egg-based influenza vaccines process into a new facility and was extensively trained in cGMP practices. At Medimmune, she also worked on upstream project development, including media de-velopment, optimization of chemostat and fed batch processes and scale-up experiments.
Youjin earned her M.S. Chemical Engineering at San Jose State University, her B.S. in Chemical En-gineering with a Minor in Chemistry and Music at the University of California Berkeley.
Duk Lee is Director of IT/IS Systems at Bionova Scientific and is responsible for all IT/IS infrastructure and operations.
Prior to joining Bionova, Duk led a DevOps team at BlackHawk Network, managing the company’s cloud infrastructures and deployments. At BlackHawk, he developed hands-on experience supporting, automating, and optimizing mission critical deployments in Amazon Web Services, leveraging configuration management, CI/CD, and DevOps processes. He has a strong track record of designing, building and managing enterprise level system architecture.
Prior to BlackHawk, Duk helped build and maintain IT infrastructure across multiple E-commerce businesses and start-ups.
Duk earned his B.A. in Economics with a Minor in Computer Science at the University of California San Diego.
Melissa Lucero-Nguyen is Director of Upstream and Lab Services at Bionova Scientific.
Since 2017, Melissa has managed the Upstream and Laboratory Services Groups at Bionova Scientific and served as interim Cell Line Development Manager. She was instrumental in establishing Bionova’s single-use platform and our best-in-class in-house perfusion operations platform. She is also an integral part of the team supporting GMP facility buildout.
Prior to joining Bionova, Melissa was a Senior Engineer at Boehringer Ingelheim where she worked in the worked in Process Science Cell Culture, Clinical Supply and Upstream MSAT groups. She worked on tech transfers, GMP troubleshooting and made significant contributions to the establishment of a single-use platform at BI Fremont. As a member of a global team, Melissa helped harmonize operational practices across 3 sites and collaborated on implementing new technology. Melissa led operational teams in the planning and execution of new product introduction (NPI) and clinical manufacturing tasks; as well as owning and managing change controls and deviation investigations. She was a member of the Inspection Readiness Team and participated in client audits as well as PAI readiness audits. Melissa also worked cross-functionally on facility design and estimating CAPEX, OPEX and plant capacity. She served as project manager to onboard and validate equipment for the disposable manufacturing facility.
Melissa also held prior positions at Eli Lilly and Biogen, where her work included media optimization studies, process simplification, stability studies, scale down modeling, and the investigation of perfusion technology in various cell culture stages. Melissa also led a small team of scientists working on various development projects.
Melissa earned her B.S. in Chemical Engineering from the University of Notre Dame.