The emerging field of biomanufacturing—or the use of biological systems to create products—is rapidly changing a wide variety of industries, from healthcare and agriculture to textiles and environmental science. Biomanufacturing professionals help to develop innovative materials as well as ensure the quality and safety of products including pharmaceuticals, biofuels, cosmetics, genetically modified crops, biodegradable plastics, and more. In addition to having specialized technical skills and knowledge, these professionals excel at their jobs through critical thinking, effective communication, and collaborative teamwork. Related life science organizations in California expanded employment by 6% in 2022, which outpaced all other industries in California and the U.S. overall during the same period.*
The Biomanufacturing Sciences and Applications program was created in response to the need to fill many different positions that are available in the biomanufacturing, biotechnology, and biopharmaceutical industries. The program provides a broad overview of scientific principles, current research, and industrial applications for biomanufacturing, including the operation and maintenance of biomanufacturing equipment. Students also learn about the diverse range of careers in professional settings such as medical labs, production facilities, and corporate offices. Depending on previous experience and education, opportunities may include entry-level roles as biomanufacturing technicians or multiple positions in research and development, quality control, regulatory affairs, and process development.
The program includes three 40-hour courses: Biomanufacturing Fundamentals; Materials, Processes, and Technologies; and Emerging Applications of Biomanufacturing. Upon successful completion of the 120-hour program, students will receive digital badges for each of the three courses as well as a badge for the full program to showcase their new skills and achievements.
The Biomanufacturing Sciences and Applications program was developed by a consortium of three California State University campuses (Fullerton, Los Angeles, and Long Beach) and Biocom California Institute, which provides workforce development tools and courses for over 1,800 member companies in California.
* According to Biocom California’s 2023 Life Science Economic Impact Report
Biomanufacturing Bridge Course
The Biomanufacturing Bridge Course is a FREE, short-term, intensive program aimed at students from a wide range of educational backgrounds who are seeking a bridge between their current knowledge and the advanced concepts and skills taught in CSU's Biomanufacturing Science and Applications certificate program. The Bridge Course incorporates hands-on experience with two advanced digital tools, Labster and Autodesk Fusion 360.
Complete the program in less than one year
Develop skills for multiple areas of the biomanufacturing industry
Learn about different career opportunities in biotechnology
Earn digital badges endorsed by industry leader Biocom California Institute
An introduction to quality standards, guidelines, and regulatory compliances
Cleaning and sanitizing of equipment
An understanding of viable career paths depending on previous experience and education
The latest technological advancements in a rapidly evolving marketplace
Recent graduates seeking entry-level job opportunities in biomanufacturing
Mid-career professionals seeking to transition or advance in a new field
High school, career technical, or community college students with a background in science
Veterans interested in gaining experience for a growing field of employment opportunities
Diverse professionals from various backgrounds who have an interest in expanding their roles in the biomanufacturing industry (including marketing, sales, HR, supply chain logistics, accounting, and IT)
Meet attendance and/or participation requirements
Pass all quizzes with a score of 75% or better
Complete all other assignments by due dates
Students who successfully complete this program are eligible to receive a Digital Badge from CSULB’s College of Professional and Continuing Education. Each Digital Badge is embedded with a link to secure and specific information confirming that the participant has obtained the necessary skills and competencies as described in the program. The badge also includes the participant’s name, the course title, and date of completion. Badges are shareable and can be uploaded to CVs, resumes, social media profiles, or other digital platforms. Click here to learn more about Digital Badges.
Program Outline
This is the first of three courses in the Biomanufacturing Sciences and Applications program. The synchronous online course is designed to provide a broad overview of the biomanufacturing environment, processes, and regulatory requirements, setting the stage for a deeper dive to subsequent courses. Students will gain insight into the manufacturing processes involved, the regulatory agencies responsible for oversight, compliance requirements, and quality control and quality management systems.
Topics Include:
Biomanufacturing Industry Overview
Nature of Science
Cells, Cell Structure and Function
Chemical Processes and Living Organisms
Drug Development Phases
Process Development
Preclinical and Clinical Trials
Regulatory Environment for Biotechnology
Quality Management Systems, Communications and Documentation
Manufacturing Environment, Manufacturing Process & Special Controlled Environment
Storage, Distribution & Supply Chain
Career Development in Biotechnology
This course provides both an overview of various biomaterials and an introduction to the emerging field of biomanufacturing processes and technologies that are currently used in the biomedical industries. Students will also gain a general understanding of technologies including CAD/CAM, process automation, and digital platforms used in modern biomanufacturing industries. Course content will be delivered online (asynchronously) with scheduled live (synchronous) office hours. Weekly courses consist of recorded lectures, quizzes, interactive assignments, readings, and discussion forums.
Topics Include:
Biomaterials and Biomechanics
Biomaterial sourcing and challenges
Biomanufacturing Processes
Computer-Aided Design and Manufacturing (CAD/CAM)
3D Bioprinting/ Additive Biomanufacturing
Industrial Automation and Smart Biomanufacturing
Single-use bioprocessing systems
Digital and Computational Platforms
This synchronous online course incorporates hands-on practice and project-based lab activities. Students will use simulation labs and other virtual methods for immersive learning experiences. Students will address equipment differences between what is used in the industries versus academic settings, as well as facility control (sterile techniques, single use of equipment) and lab skills.
Topics Include:
Introduction to Biologics
Molecular and Cellular Components of Biologics
Emerging Biologics Modalities
Key Laboratory Techniques (Virtual)
Bioscience Production Environment
Ethics in Life Science and Biotechnology
Case Studies with Recently Approved Biologics
Instructors
Dr. Brandon has over 30 years of experience in translational regenerative medicine, with expertise in neurobiology as well as cell and gene therapy product development. His work includes developing the first pluripotent stem cell-derived islet replacement therapy for diabetes and neurotrophic factor gene therapy for Parkinson’s and other diseases. Dr. Brandon started his career as a technician at New England Medical Center and received post-doctoral training in the lab of Fred Gage at the Salk Institute. He is a Trustee of the ALS Association and served as Chair of their Research Committee. He received his BS from Tufts University, PhD in Pharmacology and Neurobiology at the University of Washington School of Medicine, and a certificate in Biotechnology Project Management from UCSD and the UW Foster School of Business.
Eugene P. Brandon , Chief Development Officer, BrainXell Therapeutics
Dr. Sagil James brings more than 17 years of combined academic research and industry experience in the manufacturing field to the Biomanufacturing Technician Program. An Associate Professor in Mechanical Engineering at California State University, Fullerton, his primary research areas are Advanced Manufacturing, Smart Manufacturing, and Process Modeling and Simulation. He received his master’s and PhD degrees in Mechanical Engineering from the University of Cincinnati.
Sagil James, Associate Professor, Mechanical Engineering, College of Engineering & Computer Science, CSUF
Jerry Jiang works on Lonza’s Personalized Medicine team to improve human health through advancing new cell therapy processes. He has had a diverse career in the biotech industry, starting as a research associate at Bristol-Myers Squibb before transitioning into sales and management with companies offering products such as primary cells, media, CRO services, environmental simulation chambers, 3D bioprinters, and the clinical cell and gene therapy market. He received his BS degree in Biochemistry and Cell Biology from UCSD.
Jerry Jiang, Business Development & Clinical Applications, Lonza
Will Junker spent the first half of his career in technical roles in the biopharmaceutical industry, including manufacturing, development, testing, validation, and automation. Since then, he has held leadership positions in validation, engineering, IT, and quality. In his current role with Kite Pharma, he leads the quality organization of the Viral Vector manufacturing facility in Oceanside, CA. He earned a degree in Chemical Engineering in Darmstadt, Germany.
Will Junker, Head of Vector Quality, Kite Pharma
Elizabeth Maravilla serves as the Director of Logistics and Supply Chain at ChromaDex Corp., a global bioscience company dedicated to healthy aging and the pioneer of nicotinamide adenine dinucleotide (NAD+). Prior to Chromadex, Elizabeth held various supply chain roles with organizations such as The Coca Cola Company, McCormick and Company, Anheuser Busch Inbev, and UPS Supply Chain Solutions. She holds a Masters in Global Logistics from CSULB and an MBA from the University of Southern California.
Elizabeth Maravilla, Director of Logistics and Supply Chain, ChromaDex Corp.
Dr. Martin-Hansen specializes in the research, teaching, and learning of "how people learn science." She examines how pedagogical choices impact student learners with particular attention to how access, expectations, and pedagogy affect minoritized students in STEM. She is the Executive Director of the National Association for Research in Science Teaching (NARST), a global organization for improving science teaching and learning through research. She is also a former president of the Association for Science Teacher Education.
Lisa Martin-Hansen, Chair and Faculty, Science Education, CSULB
Michael McGinley is the director of Phenomenex’s global application laboratories, where he is in charge of generating scientific content supporting the company’s products in the clinical, food, environmental, and biopharmaceutical industries. Over his 20 years at Phenomenex, Michael has served in various product development, marketing, and technical management roles, including the commercialization of its Gemini and Clarity product lines. His fields of expertise include HPLC method development, proteomics, oligonucleotide chemistry, and protein characterization. Michael previously held positions including Associate Scientist, Project Manager, and Laboratory Head at Amgen. Michael is a recognized chromatography expert and long-serving member of the editorial advisory board of LC/GC magazine. He received his degree in Biochemistry from the University of California, Berkeley.
Michael McGinley, Director, Global Applications, Phenomenex
Dr. Hyunsook Park's research focuses on understanding the regulatory mechanisms of pathogenic fungus (candida albicans)adapting to various host environments. She also collaborates with Cern Corporation, Inc. on a project to develop and commercialize an effective, non-drug treatment for fungal and bacterial vaginosis. She obtained her PhD in Microbiology at Ewha Womans University, Korea. Upon relocation to the United States, she did her post-doctoral fellowship in the Fungal Pathogenesis Research Group at Harbor-UCLA Medical Center. Dr. Park has been teaching and conducting her research at Cal State LA since 2008.
Hyunsook Park, Professor of Microbiology, Department of Biological Sciences, Cal State LA
Dr. Edith Porter is Professor of Microbiology and Immunology in the Department of Biological Sciences at California State University, Los Angeles. Dr. Porter's research on antimicrobial effector molecules of mucosal surfaces includes a collaboration with Molecular Express, a technology company specializing in the application life science technologies. Dr. Porter is a member of the American Society for Microbiology (ASM), board member of the Southern California branch of ASM (SCASM), and a member of the American Association of Immunologists. She is a recipient of the 2020 CSUPERB Andreoli award and the 2020 ASM Education Award. She obtained her MD degree at the University of Mainz, Germany and completed a fellowship in Medical Microbiology. Upon relocation to the United States, she performed research at the David Geffen School of Medicine at UCLA and joined Cal State LA in 2021.
Edith Porter, Professor of Microbiology and Immunology, Department of Biological Sciences, Cal State LA
Glen Prosise has over 20 years of experience in the biological sciences field. He worked as a scientist at Hawaii Biotech, where he worked on biodefense and vaccine projects to develop small molecule inhibitors for botulinum toxin and anthrax lethal factor. He has also worked as an account manager for GE Healthcare, Waters Corporation, and Miltenyi Biotec, helping laboratories in their development of protein and cellular therapeutics. He has consulted on the transition of technology from academia to start-up companies, and developed the first full-face CPAP mask. Glen earned a BA in Psychology from CSULB, and both his PhD in Biochemistry and MBA from UC Irvine.
Dr. Alan Taaghol is a Quality and Information Systems executive with 20 years of experience leading global biopharmaceutical and cell therapy organizations. He directs the implementation of business process automation solutions for effective and complaint development and the manufacturing of life-saving products for patients. He earned both his PhD and MS degrees in Electrical Engineering from Syracuse University, as well as a BS in Physics from Northeastern University.
Alan Taaghol, Director, Global Quality Engineering, Kite Pharma
Dr. Xin Wen is a professor in the Department of Chemistry and Biochemistry at California State University, Los Angeles, which she joined in 2006. She has taught courses including General Chemistry, Quantitative Analysis, Instrumental Analysis, Inorganic Chemistry, Protein Structure and Function, and Introduction to Research. She has engaged many undergraduate and graduate students in interdisciplinary research at the interface of chemistry and biology, with a research lab working to solve real-world problems in biomedicine and biopharmaceuticals. Dr. Wen received her master's degree and PhD in Chemistry from the University of Rochester and was a Postdoctoral Fellow in Biophysics at Johns Hopkins University.
Xin Wen, Professor, Department of Chemistry and Biochemistry, Cal State LA
Heather is a Technical QA/IT professional, speaker, and author with over 25 years of experience in the pharmaceutical, biotech, and IT industries. She leads a team of technical professionals, facilitating workshops and mentoring at Xencor while implementing ISPE GAMP5 practices for Computer System Validation, Network Infrastructure Control and Compliance, and Data Integrity. Heather published the article "Quality Approaches to Software Management" in Quality magazine and is the author of the LinkedIn newsletter Mental Healthy. She volunteers with the American Society for Quality as chair-elect for the ASQ Software Division and holds an ASQ certification for Software Quality Engineer.
Heather Wilson , Associate Director, QA, Xencor, Inc.
Dr. Howard Xu directs and works with key bioscience stakeholders to successfully run the Cal State LA BioStart bioentrepreneurs bootcamp. With biotech R&D experience in both industry and academia, he helps oversee the university’s initiatives in promoting a strong bioscience innovation ecosystem. He has also helped secure funding from L.A. County and the U.S. Economic Development Administration. He is a Professor of Microbiology and also Director of the Post-baccalaureate Certificate Program in Biotechnology. He was honored with the systemwide 2011 Andreoli Faculty Service Award and 2018 Faculty Research Award by CSUPERB (California State University Program for Education and Research in Biotechnology). He was also awarded Outstanding Professor at Cal State LA in 2019.
Howard Xu, Director for Incubator Development and Programming, Cal State LA
Frequently Asked Questions
It is recommended that students have a basic background in science, technology, engineering, or medicine (STEM), especially for incoming high school students; as well as basic algebra skills and English language proficiency.
In addition to receiving digital badges for each of the three courses, students will earn a digital badge for the full program endorsed by the Biocom California Institute.
Complete all three courses in the program, which may include meeting participation requirements for all weekly topics, passing all quizzes, and completing a final deliverable for each course.
The program is offered twice a year and can be completed in six months.
The cost is $4,950.
While scholarships are not specifically available for this program, students may apply for a private career training loan or establish a payment plan with our Student Service Center. For more information, email cpace-info@csulb.edu or call (562) 985-5561.
We do not provide job placement. However, open positions shared by hiring companies will be shared throughout the program in Canvas, our learning management system.
All students are required to have access to:
High-speed internet (recommend at least 5 Mbps up/down; click here to test your Internet speed)
You will receive an email from our learning management system Canvas with instructions on how to access the course one week before the start of class.
Please check your spam folder if you do not see it in your inbox. Through Canvas, you will have access to the course materials, Zoom links for class sessions, program schedule, grades, and other details.
If you just registered within 24-48 hours before the first day of class, you should receive Canvas log-in instructions in 1-2 day(s). We encourage all students to register early to be able to access all course materials prior to the start of the program.
Information Sessions
Potential students interested in learning more about this program are encouraged to attend a free information session. The information sessions include short presentations by a program representative, designed to provide you with an opportunity to ask questions and learn more about the program's benefits.
Upcoming online Information Sessions are listed below when they are available. Choose a date and click the link to register for that Zoom meeting. After registering, you will receive a confirmation email with details about joining the meeting.
If no sessions are listed below, then none are currently available. Please check this page at a later date to view updated sessions.
About
About the Consortium
The consortium representing three California State University (CSU) campuses (CSUF, CSULA, and CSULB) and Biocom California Institute was developed in response to the need for CSU to expand and develop programs that meet regional labor market needs and student demand. The consortium was formed to address the workforce development needs for the biomanufacturing industry in Southern California. Its mission is to develop and promote a skilled and diverse pipeline of talent to accelerate the growth of California’s life science ecosystem.
Biocom California Institute provides workforce development tools and courses for over 1,800 member companies in California, in recognition that the unique environments of laboratories and biomanufacturing require specialized training.
Offerings of this program have either started or are under development. Please check back for information on the next offering or email cpace-info@csulb.edu.