Baccalaureate Degree

Pilot Program Application

Biomanufacturing

December 19, 2014

TABLE OF CONTENTS

2. NEED (STATEMENT OF PROBLEM) ..................................................................... 1-4 SECTION a. Description of the Proposed Baccalaureate Program ...................... 1 SECTION b. Description of the College and District ............................................. 1 SECTION c. Evaluation of Interest, Support & Demand for Proposed Program .. 3 SECTION d. Summary of Labor Market & Employer Demand ............................. 3 SECTION e. Further Evidence of Need ................................................................ 4

3. RESPONSE TO THE NEED .................................................................................. 5-8 SECTION a. Description of Existing Associate Degree Programs Within the Discipline of the Proposed Baccalaureate Degree Program ............ 5 SECTION b. Outline of How the Proposed Program Builds Upon Existing Programs ......................................................................................... 5 SECTION c. Five-Year Enrollment Projections .................................................... 5 SECTION d. Lack of Program Duplication with the UC or the CSU ..................... 5 SECTION e. Analysis of the Proposed Curriculum ............................................... 6 SECTION f. Illustrations for the Upper Division General Education Course Work……………………………………………………………………….8 SECTION g. Timeline for Planning, Implementation, Requisite Accreditation Approval, and Degree Completion .................................................. 8

4. PROGRAM MANAGEMENT/INSTITUTIONAL COMMITMENT .................................... 9-10 SECTION a. Summary of College/District Accreditation Status and Accreditation for the Proposed Program.......................................... 9 SECTION b. Verification of College and District Long-Term Effective and Stable Fiscal Management .............................................................. 9 SECTION c. Identification of Experienced Program Administration Support Staff with Time Allocated to Program .............................................. 9 SECTION d. Examples of Programs Successfully Implemented ....................... 10 SECTION e. Organizational Chart for the Pilot Program .................................... 10

5. IDENTIFIED RESOURCES ............................................................................... 11-12 SECTION a. Summary of Funding and Other Resources .................................. 11 SECTION b. Evidence of the Availability of Discipline Prepared Instructional Faculty and Student Support Services and Personnel ................. 11 SECTION c. Description of Facilities, Instructional Equipment and Supplies ..... 12 SECTION d. Analysis Showing Proposed Baccalaureate Degree Can Be Successfully Achieved with Identified Resources .......................... 12

6. FORMS (APPENDIX A) ....................................................................................... 13 A. The Signature Page .................................................................................... 13

2. Need (Statement of Problem) a. The proposed baccalaureate degree program in biomanufacturing will prepare

students for employment in the manufacturing sector of the biotechnology industry, which includes biotherapeutics, diagnostics, supplies and services, and industrial products. The degree will prepare graduates for technical and quality assurance/ control-related positions. Biomanufacturing leverages the understanding of biology to manufacture products or perform services that impact health, agriculture, the environment, and industrial needs. As a product or service progresses from discovery research through development and into production, the science becomes increasingly less isolated. Through a transformation of scale, process control, and compliance, the science of biomanufacturing lives across the product and process lifecycle within a quality management system. The applied biomanufacturing baccalaureate degree will prepare students for work within the biotechnology industry in the unique environment of biological production where the science thrives in partnership with quality and compliance.

This degree program explicitly emphasizes the applied, quantitative analysis of biomanufacturing-process design and performance. In addition, students completing the program will have sufficient preparation to sit for certification exams from the American Society for Quality (http://asq.org). Certification provides valuable, third-party recognition of industry-relevant skills, abilities, and knowledge.

b. The MiraCosta Community College District is located in North San Diego County,

along the Southern California coast between Orange County to the north and the metropolitan area of San Diego to the south. San Diego County is one of the top three life science clusters in the country. The district is approximately 35 miles north of San Diego and 90 miles south of Los Angeles. It includes the cities of Oceanside, Carlsbad, Encinitas, Rancho Santa Fe, Solana Beach, Del Mar, the unincorporated areas of La Costa, Olivenhain, and Carmel Valley as well as a portion of Marine Corps Base Camp Pendleton. Approximately 400,000 people reside in the district; 63 percent are between 18 and 64. Demographically, the district’s northern and southern halves differ in terms of age and ethnicity: the northern portion is younger and more ethnically diverse; the southern portion has a greater percentage of older white residents. The district’s student population is 49 percent white, 7 percent Asian/Pacific Islander, less than 1 percent American Indian, 4 percent African-American, and 31 percent Hispanic whereas the district resident population is 67 percent white, 9 percent Asian/Pacific Islander, less than 1 percent American Indian, 2 percent African-American, and 19 percent Hispanic.

MiraCosta College’s credit enrollment has leveled off after several years of unprecedented growth. During the budget crisis that began in 2007/08, the college’s

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basic aid status and prudent fiscal management provided additional sections of critically needed courses at a time when other institutions in the region had to significantly reduce their offerings. As the economy improved and the enrollment crunch eased, MiraCosta College experienced a leveling off rather than a marked decline in headcount and FTES.

The district’s proximity to Marine Corps Base Camp Pendleton provides members of the military and their dependents access to a quality education. The veteran population at MiraCosta College has more than doubled over the last decade as a result of the increased number of military personnel being discharged from service.

As a community partner, MiraCosta College is committed to meeting the needs of all students in its district. Veterans, in particular, have strong fundamental

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5,000

10,000

15,000

20,000

25,000

MiraCosta College Credit Headcount and FTES

Headcount FTES

0

500

1,000

1,500

2,000

2,500

3,000

3,500

MiraCosta College Veteran and Dependent Population

Currently Active Military Vet discharged one year plus

Vet discharged w/in year Dependent of Active Military

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characteristics, such as leadership skills, a reliable work ethic, accountability, the ability to follow directions, and attention to detail, that are not only desired by employers in biomanufacturing but also required in the highly regulated and quality-focused biomanufacturing sector.

c. When MiraCosta College’s Biotechnology Department surveyed 138 current and former biotechnology students, it found 48 percent were very interested and an additional 34 percent were interested in the baccalaureate degree program, pending more detail on course work developed in partnership with industry.

Dr. Sandra Slivka, Statewide Sector Navigator for Life Sciences/Biotechnology (part of the California Community Colleges Doing What Matters for Jobs and the Economy framework), supports MiraCosta College’s proposed baccalaureate degree program in biomanufacturing. Further, life sciences/biotechnology is a Priority Sector for Region 10 (San Diego/Imperial Counties). The college also has documented support for the proposed baccalaureate degree from the following local biotech companies: Genentech, MO BIO Laboratories, Gilead Sciences, Inc., Genomatica, Inc., Thermo Fisher Scientific, SAFC Pharma, Assure Controls, and Beckman Coulter. In the 2014 Talent Report on California Workforce Trends in the Life Science Industry (http://tinyurl.com/biomfg1), the quantitative survey and Burning Glass Technologies data confirm that most positions in the industry require a four-year degree (55 percent based on the survey; 62 percent based on online job postings). Manufacturing positions in biotechnology were second only to research and development in hiring over the past two years and are projected to be among the highest in the next two years. Combined, this report’s data substantiate the necessity of a four-year degree in biomanufacturing.

d. According to the San Diego Workforce Partnership’s October 2014 Life Sciences: Labor Market Analysis, San Diego is a regional hub for life sciences by business cost index (http://tinyurl.com/biomfg-three), ranking third in the U.S. behind Boston and San Francisco.

According to the same study, San Diego will experience a 20 percent increase in average annual job openings between 2014 and 2018, which equates to 332 openings per year. Current associate degree completers total 269 per year for the region, leaving a gap of 63. The study concludes that employers will need a workforce that preferably has earned bachelor’s degrees to meet the demand. Even

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if all associate degree completers enrolled in a bachelor’s degree program in biomanufacturing, a gap for qualified workers would still exist. The projected starting hourly wage for students completing the baccalaureate degree program is $35.04. Experienced workers have the potential of earning an hourly wage of $59.08, which is well above the median living wage for the region of $43.73.

e. In a November 2014 report published by Biospace, data was parsed from the

Bureau of Labor Statistics and the 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production to determine the top 10 careers based how much demand for the career is expected to grow by 2022 (http://tinyurl.com/biomfg-four). In that report, bioproduction technicians were found to be in the top 10 with a median annual salary of $81,480.

The production environment in biotechnology is very different from the research/lab environment addressed by existing baccalaureate degree programs in the area and statewide. According to the October 2014 Life Sciences & Biotech Middle Skills Workforce in California report (http://tinyurl.com/biomfg-two), manufacturing technician and production technician are both in the top 10 job postings in California. Regional demand and supply data contained in the reference for San Diego County show a mismatch of supply and demand of 190 annually. This means up to 190 middle skill positions, including biomanufacturing, are not being met by educational supply. Since the majority of hiring in this industry requires a bachelor’s degree, and biomanufacturing education at that level does not exist, companies carry the burden of providing extensive in-house, on-the-job training (source: Genentech). At the same time, these employees, by benefit of employer-provided training, are now more employable within the industry and have been shown to have lower retention levels (source: Genentech). An additional outcome of the proposed baccalaureate degree program is to eliminate or greatly reduce this burden for local biomanufacturers and maintain the region as a responsive and supportive site for companies to do business. MiraCosta College can address the current supply and demand gap for available biomanufacturing jobs in San Diego County by offering this baccalaureate degree.

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3. Response to the Need a. In 2013/14, MiraCosta College’s Biotechnology Department had enrollments of 343

students with an unduplicated headcount of 194 and a full-time equivalent of 41 students. Success rates over the past 5 years have ranged from 71 to 78 percent, and retention has ranged from 82 to 86 percent in that same timeframe. The associate degree requires 38 to 44 units of major course work. The college has conferred 24 degrees and 99 certificates in the past 5 years. Students pursuing the associate degree are often on track for transfer, but job placement among all certificate and associate degree holders is better than 80 percent.

Four other colleges within the region offer an associate degree with the same CCCCO TOP code designation as the MiraCosta College biotechnology program; however, none of these programs is exclusively focused on biomanufacturing. Southwestern College, approximately 50 miles from MiraCosta College, offers an associate degree in biotechnology that requires 32 units of major courses consisting of biology, chemistry, and intermediate algebra. According to the California Community Colleges Chancellor's Office MIS Data Mart, Southwestern College has conferred 31 program awards since the program’s inception in 2005/06. The San Diego Community College District (SDCCD), which shares curriculum among three colleges, offers an associate degree in applied biology. This program requires 31 to 35 units of major course work consisting of biology, chemistry, and an introductory computer information science course. Two required courses that focus specifically on biotechnology are offered only at the district’s Miramar College campus. According to the data mart, SDCCD has conferred 19 program awards in this TOP code since the program’s inception in 1996/97.

b. MiraCosta College’s Biotechnology Department currently offers three certificates and

one associate degree. The proposed baccalaureate degree program will explicitly build upon the department’s current curriculum in science, statistics and data analysis, technical skills, abilities, and knowledge, and foundational quality and regulatory topics so current students can transfer seamlessly into the baccalaureate program. The program will be an option to students who have completed related degree and certificate programs within the region.

c. MiraCosta College projects an annual cohort enrollment of 24 students. The first

cohort will begin the upper division portion of the program in fall 2017 and graduate in spring 2019. Each subsequent year a new cohort will enroll and graduate. The college projects 96 to 100 total graduates over the 5-year period based on an estimated completion rate of 80 percent in the associate degree in biotechnology.

d. Seven programs at UC/CSU campuses refer to biotechnology as the title of either a

major or a concentration within a biology or plant sciences major. No programs within either segment are titled or reference biomanufacturing. The proposed

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baccalaureate degree program does not duplicate the program outcomes or curricular requirements of any UC/CSU biotechnology program. The primary and substantive curricular difference between the biomanufacturing program and existing CSU/UC programs is the proposed program’s development of specific biomanufacturing skills, supported by a strong foundational knowledge of science, that will qualify graduates for technician-level employment in the biotechnology business sector. As demonstrated below, the existing CSU/UC programs emphasize either skills broadly relating to biotechnology or pathways to graduate programs.

CSU UC

CSU Campus: Degree

Program Emphasis

UC Campus: Degree

Program Emphasis

Bakersfield: BS Biology, Biotechnology option

Evolution and the relationship between organisms and the environment.

Davis: BS Biotechnology

Current and potential applications for nutritional quality of food crops; disease resistance in plants and animals; crop and livestock productivity.

Northridge: BS Biology, Biotechnology option

Biotechnology or cellular and molecular biology in medical, industrial, agricultural, or other applications.

Riverside: Plant Biology, BA/BS Plant Genetics, Breeding and Biotechnology Option

Modern principles and research practices of basic plant biology.

Pomona: BS Biotechnology

Theoretical and practical industrial applications of biological phenomena, with an emphasis on cell and molecular biology.

San Diego: BS Bioengineering: Biotechnology

Bioengineering topics of biochemistry and complementary fields of cellular physiology.

San Marcos: BS Biological Sciences, Concentration Biotechnology

Solid foundation in molecular biology, immunology, and biochemistry.

As the college is within the CSU San Marcos (CSUSM) service area, MiraCosta College Vice President of Instructional Services Mary Benard and Biotechnology Department Chair and Professor Mike Fino met with CSUSM Provost and Vice President for Academic Affairs Dr. Graham Oberem and Biotechnology Faculty Lead Dr. Matthew Escobar to discuss the proposed biomanufacturing degree, its potential program outcomes, and its curriculum. Both Oberem and Escobar supported this proposal, stating in writing that the two colleges’ biotechnology baccalaureate programs can co-exist without duplication.

e. The biomanufacturing degree program has two core tracks: biomanufacturing science and technology and biomanufacturing quality.

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Biomanufacturing Science & Technology Biomanufacturing Quality Process Sciences (Lec/Lab) • Fundamental physical and chemical principles

and technologies enabling large scale biomanufacturing

• Thermodynamics and the properties of fluids; mass and heat transfer, fluid flow, and the energy relationships in fluid systems

Statistical Process Control (Lec/Lab) • Concepts and methodology for measuring

and controlling quality during the manufacturing process; control charts, process capabilities

Design of Experiments for Biomanufacturing (Lec/Lab) • Formal methods in connecting process

parameters and quality attributes towards improved process understanding

• Full and fractional factorial experimentation

Global Quality System Regulations (Lec) • Study of the harmonized quality system

approaches of ICH Q8, 9, 10, and 11, including quality risk management, qualification, and validation

Design of Biomanufacturing Processes and Equipment (Lec/Lab) • Advanced course work in the design of processes

and equipment in biological production, recovery, and purification within a quality framework

• Aseptic process design, fitness for use, critical utilities, modes of operation

Six Sigma and Lean Manufacturing (Lec/Lab) • Study of key six sigma concepts and tools;

the DMAIC phases: design, measure, analyze, improve, and control

• Use and implementation of lean tools to reduce waste

Bioprocess Monitoring and Control (Lec/Lab) • The measurement, monitoring, modeling, and

control of biomanufacturing processes

Methods in Quality Improvements and Investigations (Lec/Lab) • The study of continuous quality

improvement techniques, including investigational methods into process deviations

Seminar in Biomanufacturing Technologies (Lec) • Advances and current technology in biological

production and purification operations

Seminar in Biomanufacturing Quality (Lec) • Advances and current practices in

biomanufacturing quality

Prior to enrolling in the program, students will be given the baccalaureate degree’s course requirements as well as a two-year education plan of specific major course offerings. The chart below illustrates how a full-time student’s educational plan will be structured.

Lower Division Biotechnology associate degree or equivalent preparation

Upper Division, Year One

Fall Term • Process Sciences • Design of Experiments for Biomanufacturing • Global Quality System Regulations • Other courses

Spring Term • Design of Biomanufacturing

Processes and Equipment • Statistical Process Control • Upper Division GE • Other courses

Upper Division, Year Two

Fall Term • Bioprocess Monitoring and Control • Six Sigma and Lean Manufacturing • Seminar in Biomanufacturing Technologies • Upper division GE

Spring Term • Methods in Quality Improvements and

Investigations • Seminar in Biomanufacturing Quality • Upper division GE • Other courses

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f. Students will complete 9 to 12 units of upper-division course work. Upper-division general education courses will integrate discipline concepts with the broadly defined MiraCosta College general education outcomes specific to the areas of effective communication, critical thinking, and global awareness. Courses under consideration include the following:

• Advanced Technical Writing for Regulated Environments: Advanced technical writing applied to a variety of documents, including reports, standard operating procedures, batch production records, and investigations.

• Public Health/Principles of Epidemiology: Application of epidemiologic procedures to the understanding of the occurrence and control of infectious and chronic diseases, mental illness, environmental health hazards, accidents, and geriatric problems.

• Leadership Skills and Team Dynamics: Leadership concepts and skills (e.g., psychological process, conflict resolution, counseling, and human service skills) and awareness and development of personal leadership styles.

g. The following chart illustrates the timeline for program planning, implementation, requisite accreditation approval, and degree completion.

As noted in the timeline, the college will prepare a substantive change proposal for the Accrediting Commission for Community and Junior Colleges beginning January 2015 for submission in August 2016. The substantive change proposal will be developed in tandem with the college’s 2016 self-evaluation for reaffirmation.

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4. Program Management/Institutional Commitment a. MiraCosta College is accredited by the Accrediting Commission for Community and

Junior Colleges (ACCJC), Western Association of Schools and Colleges. In 2012, ACCJC reaffirmed the college’s accreditation and removed a probation sanction from the previous year, noting MiraCosta College had “done a thorough job responding to Commission recommendations.” The college is currently preparing its self-evaluation for a spring 2016 site visit as part of its regular cycle of quality review. MiraCosta expects to receive approval of the substantive change in fall 2016, prior to program implementation in fall 2017.

b. Due to its basic aid status, the district is able to provide programs and services that

otherwise would not be possible. Thus, the district can and will commit various sources of appropriate funding toward implementation of the proposed baccalaureate program, including funds from the general fund, instructional equipment, appropriate categorical funding, and capital outlay.

The district receives approximately 87.5 percent of its unrestricted general fund monies from property taxes. For 2014/15, the district is expecting to receive approximately $82,100,000 in property taxes (2014/15 budget), combined with student enrollment fees of $12,700,000 and Proposition 30 revenues of $1,100,000. Revenues for 2014/15 are $41,800,000 more than the state’s total computational revenue that would normally be allocated from the state to the district. Furthermore, according to the November 2014 Legislative Analyst’s Office Fiscal Outlook, the statewide average for property taxes is projected to increase 5.5 percent in 2015/16 and will grow approximately 6 percent each year through 2019/20. By potentially receiving up to $5 million of additional property tax revenues each year through 2020, the district will be in a strong position to financially support the program.

From a cost perspective, the district spends approximately 82 percent of its budget on wages and benefits. This relatively low “wages and benefits-to-total expenditure” ratio further enhances the district’s ability to support the program. The district’s unrestricted general fund ending balance for June 30, 2015 is expected to be $14,100,000 (i.e., 14 percent of the district’s expenditure budget), which is nearly three times the state’s 5 percent minimum. The healthy ending balance provides sufficient cash flow so the district can avoid borrowing funds for cash flow purposes. From a compliance perspective, the district has had unqualified audits and no findings since 2010/11. These financial resources and strong internal controls will support the planning and implementation of the proposed baccalaureate program.

c. The proposed biomanufacturing program will be led by Biotechnology Department Chair and Professor Mike Fino. Fino has been at MiraCosta College for more than 10 years and currently serves as the Academic Senate president. Prior to MiraCosta College, he spent 8 years working in various bioprocess engineering capacities from research, product development, and manufacturing support for tissue-engineered medical products. Fino is currently a co-principal investigator on a National Science Foundation Advanced Technology Education grant to promote the development of a biomanufacturing educational infrastructure.

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5. Identified Resources a. As outlined in the response to 4b, MiraCosta College’s strong current and projected

financial position will provide sufficient financial resources to support baccalaureate program planning, implementation, curriculum development, and professional development. New curriculum will make use of the well-established curriculum development and approval process managed by the college’s curriculum committee, which ensures the academic integrity and quality of all new courses and programs. Additionally, MiraCosta College will augment existing professional development funding as necessary to provide additional or specialized training for the baccalaureate degree program. The Biotechnology Department’s associate degree and certificate programs are well equipped to meet the resource requirements for a biomanufacturing baccalaureate degree program. The current biotechnology associate degree program has earned grant funds totaling over $200,000 for 2014/15. These funds will augment needed equipment for existing labs.

b. Professor Fino will serve as the faculty lead in curriculum development. As

previously noted, he has more than 18 years of industry and education experience and is a nationally recognized leader in biomanufacturing curriculum. Professor Baughman brings more than three decades of industry and education experience and has a demonstrated track record of translating industry needs into educational programs. Further, Dr. Vivian Ngan-Winward, a part-time faculty member, most recently lead the biomanufacturing program at Salt Lake City Community College where she implemented the NSF-funded STUDENTfacturED training enterprise to give students a real-world biomanufacturing experience. In order to ensure students in the program have appropriate student support services to maximize student success, MiraCosta College will dedicate support staff in the areas of financial aid and scholarships, career exploration and internships, disabilities and accommodations, and tutoring. Additionally, baccalaureate program students will receive support in admissions, evaluation, counseling, and tutoring throughout the program to provide critical elements to student success, including completion of the matriculation process, and educational plan development, including recommended semester-by-semester pathways, to realistically and efficiently complete the degree. The MiraCosta College Library provides instructional support for all students through 24/7 access to online resources, including general academic and specialized databases, more than 150,000 eBooks, and streaming media. The library has access to approximately 75 e-journals in the subject area of biotechnology. Librarians provide research support to all students at reference desks and through customized instruction to meet the research needs of individual classes and departments. They also coordinate with academic librarians throughout the U.S. to provide a 24/7 online chat reference service.

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c. Instructional activities at MiraCosta College will be conducted primarily in a 3500 square foot dedicated teaching laboratory space, which features a traditional laboratory classroom, reagent weigh room, bioprocessing suite, and bioprocess support area. The laboratory classroom accommodates 30 students, and the lab benches have 30 sets of drawers that each contains a full complement of lab essentials and liquid handling tools. The remainder of the lab is equipped with all the equipment, instruments, and supplies for fundamental instruction in biotechnology methods. The bioprocessing suite accommodates 24 students and, as a team-based environment, contains six sets of the lab essentials and liquid handling tools identified above. The flow of bioprocessing suite is designed to mimic the flow of a bioprocess. First, materials are cleaned and sterilized with an in-wall autoclave at one end of the room. Next, a set of biosafety cabinets and CO2 incubators allow for the establishment of seed cell cultures. From there the process moves into process-controlled bioreactors. The suite has the capacity for six, 3-L controlled reactors attached to Broadley-James BioNet, DeltaV systems. Finally, the process is completed with recovery and purifications with six sets of GE Healthcare Quixstand tangential flow filtration systems and GE AktaPrime column chromatography systems. The lab is well-equipped for fundamental and advanced instruction in biomanufacturing. Additional equipment will be identified through the curriculum development process and discussions with the Industry Advisory Board.

d. On December 10, 2014 the MiraCosta College Board of Trustees unanimously approved resolution 9-14/15, enthusiastically supporting the district’s baccalaureate degree pilot program application. In addition to having strong commitment and support from the board, MiraCosta College possesses the capacity and technical expertise necessary to be responsive to the identified need for baccalaureate-trained workers in the life science area of biomanufacturing. The college is prepared to commit resources in the form of faculty and staff time, facilities, equipment and supplies, administrative oversight and participation in program planning at the state level, and professional-development support to develop and implement the baccalaureate program by fall 2017.

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