MICHAEL C. CARROLL, MT (ASCP)
214 Second Street
Dunellen, NJ. 08812
[Send email to request phone number] 26-6197
e-mail:
SUMMARY OF SKILLS
Extensive and uniquely-broad-based, hands-on experience in QA/QC operations with
leading U.S. pharmaceutical, biotechnology and medical diagnostics manufacturers.
Particular specialization in sterile products/processes and aseptic production.
Seeking a senior management position which will utilize my knowledge, experience,
expertise, and excellent writing skills. Professional experience includes:
* In-depth experience with successful development, scale-up, approval and
launch of innovative new health-care products, methods and technologies
* Development and validation of microbiological test methods and
specifications, to the satisfaction of U.S. FDA and international regulatory
agencies
* Equipment, product and process validation, particularly aseptic processes and
support utilities (including aseptic lyophilization, depyrogenation, etc.)
* Sterile product and process troubleshooting and problem-solving
* Extensive and highly-successful management and supervisory experience with
strong hands-on technical background in a wide range of cGMP areas
* Training and management of technical/professional personnel
* Design, qualification, implementation and management of environmental
monitoring and validation programs for aseptic operations, sterilization and
depyrogenation processes
* Direct interaction with U.S. and international Regulatory Agencies on
submissions and inspections, with high rate of success/approval
CAREER HIGHLIGHTS
Discovery Labs, Inc., Totowa, NJ August 2008 - Date
Senior Manager, Quality Control/Quality Assurance
Manage QC (Microbiology, EM, validation support, OTL's) and QA functions for
production facility of emerging biotechnology company close to FDA approval for a
lung surfactant (sterile drug, aseptic production). Manage small teams of
professionals in laboratory and QA functions associated with drug manufacture,
filling and release testing. Major involvement in SOP's, documentation and
quality systems development, etc.
Schering-Plough Inc., Summit, NJ August, 2007 - August 2008
Global Quality Services - Microbiology (Consultant)
Part of small international team overseeing qualification and implementation of
"Harmonized" (USP/Ph.Eur./JP) Microbial Limits test across 20+ Schering sites and
a hundred or so third-party manufacturers/testing labs worldwide. Actively
involved in numerous Microbiology technology transfers and investigations.
Hoffmann-La Roche, Inc., Nutley, NJ March, 2000 - March, 2007
Principal Scientist, Quality Management- Microbiology: Compliance & Technical
Support
Responsible for compliance of microbiology procedures and documentation with FDA
and other regulatory agencies worldwide. Actively involved in all Q.M.
Microbiology inspections and responses, investigations, complaints, etc.. Support
methods and equipment validation efforts, training, documentation and SOP
programs. Participate in new product/process teams and validation efforts.
QM-Microbiology representative for manufacturing and analytical change control
committees.
Pharmaceutical Consulting (Independent) 1999 - 2000
Independent Consultant to FDA-Regulated Industry
Quality, Reliability, Documentation, Validation and cGMP Compliance
Consultation with Ortho Biotech, Inc., Raritan, NJ, Quality Engineering Dept..
Osteotech, Inc., Shrewsbury/Eatontown, NJ 1998 - 1999
Senior Manager, Quality Assurance
In charge of Documentation, SOP/Specifications, Training and Audit groups within
Quality Assurance Division of this human bone/tissue processing and medical
device company. Extensive interface with Validations and Laboratory groups,
particularly on internal investigations and new product & process introductions
* Responsible for all in-house and vendor/contract-laboratory audits, and
vendor qualifications program; internal training department (including overseeing
Training Facilitator qualifications for all functional groups); product
complaints and internal investigations; and all product, process, specification
and testing documentation
* Supervise 8+ professional personnel (Auditors, Trainers, Tech Writers,
Document Coordinators)
* Leading project teams for several projects: Isolator for sterility testing,
QUMAS Documentation System, etc
The Liposome Company, Inc., Princeton, NJ 1992 - 1997
Manager, Microbiology and Princeton Manufacturing Facility Support, Quality
Control
Developed a Pharmaceutical Q.C. Microbiology and Validations Support laboratory
function "from scratch", in support of a brand-new, Clestra-designed,
multi-product aseptic manufacturing facility (clinical and commercial)
* Developed and implemented environmental monitoring and microbiological
validation/revalidation support programs
* Responsible for all in-house and contract-laboratory microbial and endotoxin
testing of raw materials and products
* Supervised up to 7 professional laboratory personnel
* Intimately involved with U.S. and international (European/U.K.) regulatory
submissions for licensure of new drug products (including inspections)
Ortho (Ortho/McNeil) Pharmaceutical Corporation, Raritan, NJ 1987 - 1992
Senior Associate Scientist/Supervisor, Microbiology, Quality & Technical Affairs
(1989 - 1992)
Associate Scientist, Microbiology, Quality & Technical Affairs (1987 - 1988)
* Responsible for microbiological validation and environmental/utilities
monitoring programs for several multi-product aseptic production facilities,
systems and products
* Responsible for methods-development and new technology transfers in
Microbiology area (LaCalhene Isolator System for sterility testing; LAL/Endotoxin
test development and validation for new products; etc.)
* Supervised professional/technical personnel
* Considerable "public-speaking" at professional meetings and symposia
(predominantly in aseptic processing/environmental monitoring areas)
Prior Experience
Solid track record in Quality Control/Quality Assurance with international
Medical Device/Diagnostics/Small-Volume Parenterals manufacturer
* Managed three QA/QC laboratory groups and up to fifteen professional
employees
* Managed QA/QC involvement in multiple new-product introductions in many
different product groups
Publications Highlights:
"Microbiological Validation of a New Manufacturing Complex for an Injectable
Biological Product" - Journal of Parenteral Science and Technology, Vol. #46, No.
4, Jul./Aug. 1992
Isolator Technology: Applications in the Pharmaceutical and Biotechnology
Industries - Edited by Carmen M. Wagner and James E. Akers - Interpharm Press,
Inc., 1995 - Chapter 8: "Microbiological Monitoring and Control in Isolator
Systems"
Microbiology in Pharmaceutical Manufacturing - Edited by Richard Prince - Davis
Horwood Intl Publishing Ltd., 2001 - Chapter 19, "A Multifaceted Look at the
Microbial Limits Test"
EDUCATION/PROFESSIONAL
Medical Technology (ASCP-Certified): Pennsylvania Hospital, Philadelphia, PA
(1974)
Bachelors Degree (Biology): University of California at San Diego, La Jolla, CA.
(1973)
Professional: American Society of Clinical Pathologists (ASCP) - Board of
Registry Certification, Medical Technology
Parenteral Drug Association, Inc. (PDA) - Member
Professional Bowlers Association (PBA) - Member
214 Second Street
Dunellen, NJ. 08812
[Send email to request phone number] 26-6197
e-mail:
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