Post-Baccalaureate Certificate in Biotechnology Management
The Post-Baccalaureate Certificate in Biotechnology Management is designed for life science professionals interested in or currently leading teams or starting a company. The four-course certificate program provides a foundational understanding of management and business processes within the biotechnology field. The courses are taught by industry professionals with extensive practical experience in the subjects they teach.
Learning Outcomes
By the end of this program, you will be able to:
- Gain a better understanding of how the biotechnology industry operates
- Discuss legal and ethical issues relevant to the life sciences industry
- Learn project management tools and principles to more effectively bring biotechnology projects to commercialization
- Strengthen interpersonal skills resulting in improved organizational leadership skills
- Be able to develop a commercialization plan for bringing a biotechnology product to market
Required Courses
This certificate requires the following four courses:
BTEC 665: Management, Leadership and Communication
This course teaches the fundamentals of management and managerial leadership and communication. Managers juggle operations, finance, information technology, strategy, and projects, yet much of their success depends less on their own direct input than on their ability to enlist the active involvement of others: direct reports, other managers, other team members, and those above them on the organizational chart. It is imperative, therefore, that managers be adept at influencing those over whom they have no formal authority as well as guiding and directing those who report to them.
BTEC 670: Legal & Ethical Issues in the Science Professions
This course offers an overview of legal issues affecting biotechnology and other science-based industries and frames basic philosophical and ethical considerations regarding genetic data and manipulation. The course includes a discussion of intellectual property issues.
BTEC 675: Business Principals of the Biotechnology Industry
This course is an overview of the life science industry, current and future trends. In depth discussions of the relationship between science and business and the process by which biotech products are designed, developed and brought to market. Course topics will include, biotechnology entrepreneurship, starting, leading and managing biotech companies, and comprehensive thesis on the workings of the biotechnology industry.
BTEC 685: Project Management Fundamentals
Students learn the fundamentals of managing projects in a systematic way. These fundamentals can be applied within any industry and work environment and will serve as the foundation for more specialized project management study. Principles and techniques are further reinforced through practical case studies and team projects in which students simulate project management processes and techniques.
Post-Baccalaureate Certificate in Biochemical Regulatory Engineering
Taking a new biotechnology product through a lengthy and rigorous FDA approval process can be a daunting experience. But knowing the internal framework of the FDA review and marketing authorization process can be a significant advantage.
UMBC’s post baccalaureate program in biochemical regulatory engineering guides students through the ins and outs of the FDA process and explores the numerous considerations that can help ensure product approval and sustainable regulatory compliance status. Professionals from leading bioscience companies and government agency organizations participate in this post-baccalaureate certificate program. Guest lecturers also from private entities and public organizations, with direct hands-on experience on the various topics, are featured frequently in all the courses of the program.
Learning Outcomes
By the end of this program, you will be able to:
- Understand the key steps for obtaining FDA approval of a biotechnology product
- Achieve a working knowledge of CGMP compliance, quality control, validation, and design of GMP biotech facilities
- Prepare key CGMP documents, such as batch records, SOPs, validation protocols
- Develop a QC package for key classes of biotech products
Certificate Curriculum
This certificate requires four courses. The courses may be taken in any sequence. However, it is recommended that students take ENCH 660: Regulatory Issues in Biotechnology first.
BTEC/ENCH 660: Regulatory Issues in Biotechnology
This course provides a comprehensive coverage of all steps involved with the regulatory approval process for a biotechnology-derived product. Documentation preparation for IND, NDA, BLA. Pre-clinical safety data, clinical studies, facilities inspection and scientific and regulatory principles.
BTEC/ENCH 662: Good Manufacturing Practices for Bioprocesses
In-depth coverage of developing and implementing good manufacturing practices (GMPs) in the biotech industry. Topics include building and facilities, equipment design, utilities, in-process controls, records, and adequate process validation.
BTEC/ENCH 664: Quality Control & Quality Assurance for Biotechnology Products
In-depth coverage of the key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products: quality concepts, product release testing and specifications, in-process testing, product characterization, quality assurance documentation and audits and vendor certification.
BTEC/ENCH 666: Biotechnology GMP Facility Design, Construction and Validation
Presents an in-depth discussion of the engineering design of a biotech facility under GMP compliance. Topics covered include bulk plant design, process equipment design, utilities, instrumentation, controls and computerization, facility and software validation.
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