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JAMES A.

FOUNTAIN
5840 Mustang Court, Indianapolis, Indiana 46228-1688
317.507.4849
biljam@comcast.net

MANAGER / DIRECTOR / CONSULTANT OF BIOTECH MANUFACTURING AND QUALITY ASSURANCE

PROFILE OVERVIEW
- Seasoned Biotech Manufacturing expert with 20 years of well-rounded expe
rience in regulatory aspects and consulting areas specializing in Quality Assura
nce, Vendor Audits, Document Review, Site Acceptance Testing (SAT), SOP Writing,
and System P&ID Review and walk downs. Extensively skilled in the execution of
Commissioning and Qualification (C&Q) Documents, Process Validation (PV), Traini
ng, Cell Culture Production Operations, Cell Culture Technical Services and Tech
nical Transfer.
- Reliable leader and a collaborative consensus builder with hands-on expe
rience working in both parent companies and CMOs (Contract Manufacturing Organiz
ations), as well as in overseeing both production and technical teams. Intuitive
mentor with broad technical and scientific knowledge combined with results-base
d project management experience. Influential negotiator; expert in motivating p
eople using inspirational leadership style and innate ability in driving continu
ous improvement.
- Thoroughly knowledgeable in Government Regulations CFR Part 210, 211, Pa
rt 820, Part 600 and Part 11. Experienced in Cell Culture bioreactor design and
startup of both Upstream and Downstream processing equipment, including CIP, SIP
, and Clean Utilities. Skilled in aseptic filling of liquids, powders, and lyoph
ilized products.

TECHNICAL SKILLS
Lotus Notes ~ MS Word, Outlook, Excel, and PowerPoint ~ Autoclaves ~ Media / Buf
fer Prep Systems (SS and Disposable) Bioreactors (SS and Disposable) ~ Sterile M
edia Holds (SS and Disposable) ~ Gas Systems ~ Cryopreservation Systems ~ CIP Sy
stems ~ Centrifuges and Homogenizers ~ Cleanrooms ISO 6, 7, 8 and 9 ~ Glass / Pa
rts Washers

PROFESSIONAL EXPERIENCE

DSM PHARMACEUTICALS INC.-GREENVILLE, NC


COMPLIANCE CONSULTANT Jan 2010-April 2010
Provide comprehensive advice and strategies in sterile production, specifically
in multifaceted review of H1N1 vaccine. Leverage knowledge of all applicable inf
ormation from validation of systems to raw materials, operations, analytical, de
viations, including CAPA and systems perspective.
- Ensured efficient and compliant function of Formulation, Sterile Fill, I
nspection, and Packaging departments
- Streamlined the release of final product by working collaboratively with
manufacturing group to correct cGMP issues with batch records
- Measured the impact of documentation and other cGMP issues associated wi
th batch release
- Achieved aggressive timelines while maintaining coordination in all asso
ciated procedures

COOK PHARMICA, LLC -BLOOMINGTON, IN


MANAGER OF MANUFACTURING TECHNICAL SERVICES MAY 2008-FEB 2009
Acted as a key point of contact for Engineering Design Firm and cross-functional
departments, including Engineering, Process Development (PD), Quality Control (
QC), Quality Assurance (QA), and Operations to achieve facility goals. Consulted
by the Quality Groups, as well as managed and maximized skills of technical ser
vice representatives and quality auditors.
- Developed and strategized the design of Process Batch Records and Proces
s Flow Charts (PFCs)
- Guaranteed the success of vendor and supply chain audits through domesti
c and international technical support
- Directed and participated in client conferences to facilitate technical
transfer, and evaluated exception and deviation reports for approval and impact
to Safety, Integrity, Strength, Purity and Quality (SISPQ)
- Achieved technical and production needs through routine management and r
esolution of issues via cross-functional departmental interactions
- Instituted the Pre-Process Overview sessions, which aimed to meet client
needs and expectations
- Examined and approved Change Management and Change Control Documents, as
well as Batch Record and SOP revisions
- Evaluated overall effectiveness of architectural and equipment drawings,
as well as Piping and Instrumentation Diagrams
(P&IDs)
- Spearheaded the composition of End of Production Run Summaries and track
ed data for Periodic Product Quality Evaluation (PPQE)
MANAGER OF MANUFACTURING MAR 2006-MAY 2008
Strategically guided the Engineering, PD, QC, and QA during commissioning and va
lidation. Oversaw and ensured performance efficiency of manufacturing associates
and supervisors.
- Key involvement in the successful development of manufacturing training
curriculum and records
- Served as subject matter expert (SME) to Quality, Engineering, Managemen
t and Development groups
- Supported multiple Manufacturing Equipment Factory Acceptance Testings (
FATs) and Vendor Quality Audits
- Developed plans and managed hiring and recruitment of manufacturing asso
ciates and supervisors for startup operations
- Authored and taught sessions on Bioreactor Sterile Operations

COOK PHARMICA, LLC -BLOOMINGTON, IN


MANAGER OF CELL CULTURE TECH TRANSFER MAR 2005-MAR 2006
Established a collaborative work environment between Engineering Design Firm, Co
nstruction Contractors, Engineering, PD, QC, and QA departments to achieve facil
ity construction and improvement plans. Defined manufacturing equipment needs an
d design requirements, as well as outlined new technical transfer process.
- Maintained overall efficiency of Quality, Engineering, Management and De
velopment groups, serving as cross-functional consultant
- Consulted with internationally recognized Engineering Design Firm to res
olve facility and equipment design issues.
- Determined areas for improvement and implemented systems for usage of Di
sposables Technology
- Evaluated viability of SOPs for newly constructed Biotech facility

ELI LILLY -INDIANAPOLIS, IN


SENIOR CELL CULTURE TECH SERVICES REPRESENTATIVE AUG 1997-MAR 2005
Key role in the successful transfer of a perfusion cell culture process to the p
roduction Contract Manufacturing Organization (CMO) in partnership with Engineer
ing, Process Development, Quality Control and Quality Assurance departments.
- Ensured that cGMP standards were consistently followed by maintaining co
mmunication between CMO Operations Directors, Operations Managers, Quality Assur
ance personnel and the Parent Company
- Appointed as the first member of any client Technical Group permanently
relocated to be client "Man-in-the-plant" at a particular East Coast CMO facilit
y; acquired a unique insight to CMO / Client relationships that few have to date
- Partnered with large-scale Media Manufacturers (including time in their
facilities) to resolve production issues, and was viewed as an authority in the
use of media bag (disposable) technology in a cGMP production facility
- Facilitated thorough vendor audits and provided support to identify, ass
ess and eliminate contamination vectors of entry
- Initiated improvement in existing operations and proactively contributed
in daily onsite CMO production meetings
- Played a pivotal role in End of Production Run Summaries and PPQE data,
as well as in the success of inspections by Team Biologics, European, Mexican an
d Canadian agencies

PRIOR EXPERIENCE
Eli Lilly (Indianapolis, IN)
Cell Culture Tech Services Representative (1995-1997)
Senior Process Technician (1988-1995)
Various Positions (1973-1988)

EDUCATION
(BS) BACHELOR OF SCIENCE IN MICROBIOLOGY ~ GMORE Theological Seminary of America
-Munster, IN
(MS) MASTER OF SCIENCE IN BIOTECHNOLOGY AND BIOINFORMATICS ~ GMORE Theological S
eminary of America-Munster, IN
OPERATING ROOM TECHNICIAN TRAINING, OPERATING ROOM TECHNICIAN CERTIFICATE ~ Meth
odist Hospital-Indianapolis, IN

PROFESSIONAL TRAINING
The American Society of Mechanical Engineers (Bioprocess Technology Course)
Society of Bio-Processing Professionals-Development and Scale-up of Fermentation
and Cell Culture Course
Performance Excellence Team Leader Course
Interaction Management Program
Center for Continuing Education (Biopharmaceutical Production Technology Course)

AWARDS AND HONORS


- President's Award presented in 2004 for â⠬ŠOutstanding Scientific Achievements Co
tributing to the Success of the Global Lilly Research Laboratories Community"
- Inaugural plaque on the "Lilly B358 Safety Wall of Honor" Awarded for le
ading first ever Lilly Ergonomic Assessment Team
- Lilly Research Technologies and Product Development "Changing the World"
Award

ACTIVITIES
- Habitat for Humanity Volunteer
- Menâ⠬⠢s Shelter (Providing transitional housing for men returning to society aft
being incarcerated)
- A preferred mentor and consultant to former dir

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