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Biotechnology Manufacturing Certificate

The certificate is geared toward professionals, including manufacturing engineers, drug discovery and development scientists and engineers, clinical research associates, QA/QC and regulatory specialists, and purchasing and facility personnel who want to improve their knowledge of biotechnology manufacturing. The curriculum for this certificate program has been created to present the issues unique to the biotechnology industry, as well as those common to the field of manufacturing. The certificate provides the technical professional a broad exposure to key biotech manufacturing processes and good practices, as well as project management, quality, regulatory, validation and calibration issues. Classes cover current manufacturing best practices such as economics and process management. The program electives offer sufficient flexibility from which the student can complement the core curriculum with courses most appropriate to their job requirement and career development needs.

This program is designed for professionals with a limited formal training in biotech manufacturing, who now seek to improve their fundamental understanding of the core knowledge areas. The curriculum is practical, teaching basic manufacturing processes and good practices, tools, and practical skills. The instructors bring with them many years of practical workplace experience in the subject that they teach and expose the students to many real workplace examples.

Professional certificate programs from the University of California have enjoyed increasing recognition among employers as evidence of academic advancement for post-baccalaureate professionals with a strong applied workplace focus. For those making career transitions, it offers university-accredited certification for the knowledge and skills acquired as part of this program. For those with significant experience in the field, but who do not have a primary degree, the professional certificate provides formal academic documentation of initiative and commitment to tackle and complete this type of advanced certified education program.

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Certificate Course Matrix
Course Title Course Number Units FA WI SP SU
Recommended Prerequisties (Students should have familiarity with the following subject areas before beginning the program.)
Introduction to Molecular Biology
BIOL-40001
3
X X 
Microbiology: Fundamentals to Application
BIOL-40247
3
  O 
Cell and Molecular Biology
BIOL-40234
3
 O O
Required Courses (All six are required.)
Introduction to Biotech Manufacturing Processes
BIOL-40040
3
  X 
Advanced Biotech Manufacturing Processes
BIOL-40011
3
 X  
Good Documentation Practices
BIOL-40201
3
   X
Good Manufacturing Practices
BIOL-40000
3
OOOO
Introduction to QA/QC for Drugs & Biologics
BIOL-40038
3
 O O
Biotechnology Validation and Calibration
BIOL-40016
3
  X 
Electives (Six units are required)
Advanced QA/QC for Drugs & Biologics
BIOL-40021
3
O O 
Chemistry, Manufacturing and Controls
CHEM-40002
1
 O O
Overview of the Drug Development Process
BIOL-40015
3
O O 
Six Sigma Green Belt
AMES-40150
4
O O 
Regulatory Compliance for Drugs & Biologics
BIOL-40101
2
O, XOOO
L=La Jolla M=Mission Valley O=Online R=Rancho Bernardo S=Sorrento Mesa X=Location TBA
Certificate Programs

To Register in the Certificate Program

Certificate registration is required to complete the program. Candidates are encouraged to register in the certificate program as early as possible to take advantage of program benefits. See Certificate FAQs for more information.

Certificate Section ID: 073902 Register Now!
Application Fee: $50
Contact: Life Sciences, (858) 882-8027
E-mail: unexbio3@ucsd.edu

Advisors

K. A. Ajit-Simh
Consultant
Shiba Associates

Mary Lou Gibson, Ph.D.
President and Chief Scientific Officer
Virapur, LLC

Mary Schwalen
Manufacturing Education and Training Manager
Genentech

Carmen Soikoski
Director of Development Manufacturing
Gen-Probe

Reed Vickerman
Vice President, Operations
Amylin Pharmaceuticals

Anna Waters, Ph.D.
Production Team Leader
Invitrogen Corporation