Stuart Jaffe, PhD

3929 Quailwood St
Moorpark, CA 93021
Home:  [Send email to request phone number] 23-9033
Mobile:  [Send email to request phone number] 68-9230
 
An accomplished management professional with over fifteen years of progressive
experience leading Quality and Manufacturing departments in the Biotech,
Pharmaceutical and Medical Device industries. A results-driven leader with a
proven track record of implementing continuous improvement programs.

Multifunctional Areas of Expertise:

Technical Data Analysis
Product Commercialization
Parental Drug Manufacturing
Pharmaceutical Manufacturing 
Analytical and Biochemical Assay Validation
Design Control Quality Systems
Quality Project Management
cGMP, QSR and ISO Regulations

PROFESSIONAL EXPERIENCE

INVITROGEN CORP.(Camarillo, CA) 2006 - Oct. 2008
Senior Manager, New Product Quality Assurance (2007-2008)
Oversaw the commercialization of all new Immunoassay, and In Vitro Diagnostic
products
 *  Responsible for resolving all quality issues associated with new
Immunoassay, and In Vitro Diagnostic products
 *  Reviewed and approved design control specifications
 *  Led design review meetings with R & D, Marketing, Manufacturing, and Quality
Assurance
 *  Reviewed and approved design verification and validation protocols
Key Achievements
 *  Created and implemented a new design control process at two geographic sites
which led to their ISO13485 certification 
 *  Successfully oversaw the launch of Invitrogen  's first FDA regulated
Immunohistochemistry In Vitro Diagnostic kit with initial sales forecasted over
$3,000,000
 *  Successfully managed all activities for the development and manufacture of a
new Class III In Vitro Diagnostic kit under cGMP for a major customer
Senior Manager, Manufacturing (2006-2007)
 *  Managed a manufacturing department of eighteen staff members responsible for
the manufacture of monoclonal and polyclonal antibodies
 *  Assigned workload priorities to department personnel and oversaw a
$4,000,000 budget
Key Achievements
 *  Seamlessly transferred the antibody manufacturing processes from two sites
in San Francisco into one site in North Los Angeles

AMGEN INC (Thousand Oaks, CA) 2004 - 2005
Senior Manager, Contract Manufacturing
Oversaw all manufacturing activities of two contract manufacturing sites
responsible for the production of Amgen  's newest recombinant protein products
 *  Responsible for ensuring all manufacturing and quality assurance issues were
resolved in a timely manner to meet product launch deadlines
 *  Utilized CAPA and Change Control software to close all quality related
issues
Key Achievements
 *  Successfully managed the production of three validation runs of KepivanceTM
which was critical for product launch. Subsequent annual sales were approximately
$5,000,000

BAXTER BIOSCIENCES (Thousand Oaks, CA) 2001 - 2004
Senior Manager, Quality Control Lab
Managed a quality control department comprised of 48 analysts and 3 supervisors
for release testing of recombinant FVIII. 
 *  Oversaw all analytical and biochemical testing of Raw Materials, Work In
Process samples, Bulk Drug Substance and Final Drug Product with sales of
$1,000,000,000 annually
 *  Oversaw microbiological testing of in process and water samples
 *  Reported stability testing data to site Quality Assurance
 *  Resolved Out of Specification and Nonconformance issues
 *  Presented laboratory and product performance metrics to senior management
 *  Responsible for a budget of approximately $7,000,000.
Key Achievements
 *  Led a six sigma green belt project involving the implementation of an
impurity assay resulting in $75,000 of savings annually
 *  Eliminated an in process release assay, which resulted in a savings of
$13,000 per year
 *  Led a six sigma greenbelt project implementing a just-in-time inventory
system for high usage chemicals and lab supplies resulting in a $10,000 dollar
savings per year
 *  Transferred a protein sequence assay internally resulting an annual savings
of $7,500

3M PHARMACEUTICALS (Los Angeles, CA) 1997 - 2001
Senior Manager, Manufacturing (2000 - 2001)
 Promoted by senior management to manage a production department comprised of
140 production personnel responsible for manufacturing two transdermal products
with annual sales of approximately $20,000,000. 
Key Achievements
 *  Increased productivity by 20% through process improvements utilizing design
of experiment and statistical process control methodologies.
 *  Partnered with Sales and Marketing to increase new customer orders by
$2,000,000 
Manager, Quality Control Lab (1997-2000)
Managed a quality control laboratory comprised of 28 analysts and 3 supervisors
for release testing of transdermal and tablet dosage forms.
 *  Oversaw all analytical and microbiological release testing of Raw Materials,
Work in Process, and Final Drug Products with annual sales of over $40,000,000
 *  Responsible for a $5,000,000 budget.
 *  Resolved Out of Specification and Nonconformance Issues
 *  Oversaw stability studies on Transdermal and Tablet drug products
 *  Developed and reported performance metrics to site management
Key Achievements
 *  Led a six sigma greenbelt project which improved a drug potency assay and
resulted in a 50% decrease in laboratory out of specifications
 *  Decreased total backorders by $2,000,000
 *  Implemented a six sigma greenbelt project that ensured compliance with CFR
Part 11 requirements for the Quality Control laboratory which was successfully
defended to the FDA

BAXTER BIOSCIENCES (Thousand Oaks, CA) 1991 - 1997
Associate Manager, Quality Control Lab (1994 - 1997)
Managed a quality control department comprised of 10 analysts and two
supervisors responsible for developing and validating QC release assay for in
process samples of a recombinant protein
 *  Responsible for creating and implementing technical standard operating
procedures
 *  Created and implemented procedures and systems for tracking in process
samples and laboratory data

Key Achievements
 *  Worked with quality assurance to successfully implement quality systems
(change control, nonconformance investigations, data storage) into the Quality
Control department
Associate Manager, Quality Assurance (1992-1994)
Responsible for resolving quality issues associated with a novel hybrid medical
device with both an instrumentation and biological component.
 *  Provided technical and quality input for the 510(k) submission
 *  Developed specifications for the biological components of the medical
device
 *  Coordinated the design control activities of the Engineering, Research and
Development and Regulatory Affairs groups
Scientist, Research and Development (1991 - 1992)
Technical leader for two associate scientists working on the differentiating
CD34 bone marrow stem cells into various white blood cell populations.

EDUCATION
PhD - Biochemistry - University of Southern California, Los Angeles
BSc - Biochemistry - University of California, Berkeley

Adjunct Faculty, Moorpark College (Moorpark, CA) 2006 - Present
 *  Part-time Instructor for evening classes on Cell Culture, Fermentation,
Manufacturing Process Validation, Quality Control Method Development and
Validation, Good Manufacturing Practices, Government Regulations, General
Biology, Cell Biology and Molecular Biology