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