Project Manager Quality
Resume:
JOHN K. JOHN, M.S.
Keller, TX 76244 Cell # (817)-
E-mail: *******@***.***
OFFERING: Performance driven Director & Executive with a proven track
record of impressive accomplishments in the manufacturing and quality
divisions of numerous biopharmaceutical companies with expertise in multi-
site global regulatory requirements for cGxP compliance over a 22-year
career.
SUMMARY OF ACCOMPLISHMENTS
. Over twenty-two years of cGxP and Microbiology experience in the
biopharmaceutical & medical device industries for the manufacture of
ophthalmic, Rx/OTC drug products, solid doses, liquids, API (DS),
biologics, blood products, fill/finish parenteral (DP), IVF (In vitro
Fertilization) media & diagnostics for cGxP, Part 820, ICH, ISO 13485-
2003, CLIA, MDD, and CMDR compliance.
. Interviewed and offered employed at the USFDA, Division of Manufacturing
& Product Quality (DMPQ) by Rick Friedman and his team in June, 2009.
. Successfully hosted over 100 global biopharmaceutical customers and 12
global regulatory inspections including CLIA license inspections from New
York State (Golden Standard), Connecticut, and North Carolina.
. Started a Biosafety Program at Cook Pharmica as required by USDA for
genetically engineered (GE) plants to produce biologics and successfully
hosted USDA inspection to receive "Notice of Compliance."
. Headed and harmonized multi-site quality operations located in US,
France, Germany, and the UK for a genomic laboratory service organization
who partnered with global biopharmaceutical customers.
. Managed and developed numerous direct and indirect reports in my career
ranging from non-exempt employees to exempt Senior
Scientists/Microbiologists, Clean Room Operators, Quality Engineers, Lead
Chemists, Supervisors, and Managers with MBA, CPM, ASQ and CQA
credentials.
. Superb organizer, resourceful innovator and energetic adept multi-tasking
Project Manager in a fast-paced dynamic & competitive work environment.
. Demonstrated working knowledge of MS Project, LIMS, GMPharma, Documentum,
EDMS, Catsweb, MES, Trackwise, and MAXIMO.
. Leader and Green Belt of Lean Manufacturing, Value Stream Mapping, 5S &
Kanban Supply Chain principles, and Kaizen projects.
. Saved over $250,000 annually through Kaizen projects.
. Demonstrated progressive performance to meet 100% Key Operating Metrics
at Alcon Laboratories.
. Awarded the third quarter and 2002 year award for Continuous Improvement
(CIP) at Alcon Laboratories as part of Lean Manufacturing.
. Received perfect scores in 5S audits for Quality Control Labs (Chemistry,
Microbiology, & Raw Materials).
. Conducted audits of suppliers/vendors and contract testing &
manufacturing facilities for global cGxP and ISO regulatory compliance.
. Certified Lead Auditor for ISO 9001:2000 Standard, BSI Management
Systems.
. Tenacious Team Leader for investigations that identified and corrected
sources related to sterility failures, adverse trends in bioburden,
environmental controls, mold and mycoplasma contamination of products and
clean rooms that saved companies millions of dollars in revenue and FDA
scrutiny.
Started, designed and reorganized several quality (QC/QA) organizations for
different companies to comply with cGMP in preparation for successful PAIs
including companies who received warning letters from the FDA for
deficiencies and regulatory compliance violations. Created, updated,
validated methods, equipment, HVAC, utilities and implemented systems for
new and existing facilities to comply with USP, EU and JP guidelines for
routine monitoring, aseptic bulk and final product filling processes.
2. Led five Pre Approval Inspections (PAIs) with zero 483s
successfully.
Selected to give a key presentation on environmental monitoring and water
testing at the FDA Type C meeting held at the FDA/CBER Office of Compliance
and Biological Quality in Rockville, Maryland.
Contributed to the preparation and submissions of BLA, IND, NDA, and ANDA
documents to the FDA.
John K. John
Page 1
EXPERIENCE
COOK PHARMICA LLC (A division of Cook Medical), Bloomington, IN; July 2009
- Present
Senior Director, Quality Compliance
QA/QC Compliance: Subject Matter Expert (SME) for Microbiology and aseptic
processing. Responsible for hosting all customer and global regulatory
audits. Accountable for internal/vendor audits and manage quality systems
for multi-client, multi-product CMO facility for pre-clinical, phases I -
III and commercial manufacturing. Currently working with DNV (Norway) for
ISO 13485-2003 certification. Audit scheduled for July 5-8, 2011.
Additional responsibilities include: Executing all batch release
activities. Facilitating timely completion of deviations, CAPA, Root Cause
Analysis, OOS, OOT, EM, & utilities investigations, and Change Control
processes. Supporting validation and all QC activities. Training all
employees on cGxP in preparation for PAIs. Biologics: API bulk, monoclonal
antibodies, and injectables. Medical Device: IVF (In Vitro Fertilization)
media and diagnostics. Bioreactor fermentation, barrier isolator filling
technology of syringe/vial, and lyophilization (21CFR; Parts 11, 210, 211,
820; ICH Q1 - Q10; ISO 9001; 13485-2003, CMDR SOR/98-282: MDD 93/42/EEC;
and Eudralex Volume 4) compliance.
COGENICS, Inc. (A division of Clinical Data), Houston, TX; March 2007 -
June 2009.
Senior Director of Global Quality Operations (Layoff - Company Acquired)
QA/QC Compliance: Responsible for the development of Microbiology and
Genomic Lab services & implementation of Quality Systems to maintain cGxP,
ICH, CLIA, & ISO regulatory compliance for the pre-clinical, clinical
(phases I-1V) and commercial manufacturing of drug products. Accountable
for CAPA, Change Control, OOS, OOT, Training, Validation, Method
Validation, Technology Transfer, Customer Complaints, Supply Chain, Global
Vendor/Supplier audits, and PM/Calibration activities in the US, France,
Germany and the UK. Responsible for all quality agreements, surveys and due
diligence. Harmonized quality systems in multi-site global operations for
business development in collaboration with Purchasing, Sales, Marketing,
IT, Finance, Legal and Manufacturing departments. Genomic Lab Services for
biopharmaceutical industry (21 CFR; ICH Q1 - Q10; and ISO 9001-2000)
compliance.
MORTON GROVE PHARMACEUTICALS, INC., Morton Grove, IL; May 2005 - March
2007.
Director, Quality Systems - cGMP Compliance & Audits (Layoff - Company
Acquired)
QA/QC Compliance: Managed the day-to-day functions of the Quality group
(Chemistry, Microbiology, Metrology, Receiving & Inspection and QA) and
supported Manufacturing operations for regulatory compliance. Worked
closely with all departments for business development and project
management. Responsible for improving the company's business process and
performance. Reviewed & audited CMC and NDA/ANDA submissions for compliance
and accuracy. Managed all Change Control, QC labs, OOS, OOT, EM & utilities
excursions, Audits, Customer Complaints, MedWatch reports, Field Alerts,
and Recalls in collaboration with Purchasing, Sales, Marketing,
Manufacturing, Warehousing /Logistics, Finance, IT, and Legal departments.
Hosted all regulatory inspections from the FDA, ATF and DEA. Generic drug
products, Rx/OTC, API, and therapeutic topical skin products (21 CFR; Parts
11, 210, 211, and ICH Q1 - Q10) compliance.
NeoRx CORPORATION, Denton, TX; March. 2004 - April 2005.
Plant Quality Manager (Layoff - Plant Shutdown).
QA/QC Compliance: Managed the day-to-day functions of the Quality group
(Chemistry, Microbiology, Metrology, R&I Inspection and QA) and supported
Manufacturing operations for regulatory compliance of radiopharmaceutical
fill lines. Managed all Change Control, CAPA, Non-conformance reports,
Technology Transfer, Audits, Customer Complaints, and QC labs in
collaboration with Purchasing, Sales, Marketing, Manufacturing, Warehousing
/Logistics, IT, Finance and Legal departments. Site expert for all clean
room operations and aseptic processing. API drug products (21CFR; Parts 11,
210, 211; ICH Q1 - Q10; and Eudralex Volume 4) compliance.
John K. John
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ALCON LABORATORIES, Fort Worth, TX; July 2001 - February. 2004.
Senior QA Process Control Engineer.
QA/QC Compliance: Managed the day-to-day Compliance operations of fill
lines, Exceptions, LIMS, Change Control, CAPA, Batch Release, Audits,
Customer Complaints, Start-up lines, Microbiology technology transfer,
validation, media fill failure investigations, method transfer, Management
Reviews, Annual Product Reviews (APRs), and supported Manufacturing
operations. Microbiology Subject Matter Expert (SME) for all clean room
operations, aseptic processing, and sterility assurance. Provided support
in the review and preparation of CMC sections and BLA submissions.
Participated in all regulatory inspections for microbiology related
expertise: FDA EMEA, PMDA, TGA, ISO (TUV) and from other global regulatory
bodies. Ophthalmic, Rx/OTC, solid doses, & biologic drug products (CFR Part
11, 210, 211; ICH Q1 - Q10; and Eudralex Volume 4), contact lens products &
medical devices (21CFR; Part 820, CMDR, MDD, ISO 9001-2000 & 13485-2003)
compliance.
BASF BIORESEARCH/ABBOTT CORPORATION, Worcester, MA; February 1999 - May
2001.
QC Microbiology Supervisor II: QA/QC - Responsible for day-to-day
operations of the microbiology lab and supported QA and Manufacturing
operations for all contract manufacturing of biologic products in
collaboration with Purchasing, Sales, Marketing, Manufacturing,
Warehousing /Logistics, IT, Finance and Legal departments. Provided support
in the review and preparation of CMC sections. Hosted all regulatory
inspections: FDA, MHRA & EMEA. API bulk, monoclonal antibodies, biologic
products (21CFR; Parts 11, 210, 211; ICH Q1 -Q10; and Eudralex Volume 4)
lyophilization and bioreactor fermentation compliance.
BIOPURE CORPORATION, Cambridge, MA; February 1997 - February 1999.
QC Microbiology Supervisor: QA/QC - Responsible for day-to-day operations
of the microbiology lab and supported QA and Manufacturing operations for
multi-site biologics (synthetic blood products) production activities in
collaboration with Purchasing, Sales, Marketing, Manufacturing,
Warehousing /Logistics, IT, Finance and Legal departments. Supported all
Start-up and pilot plant production including Technology Transfers.
Provided support in the review and preparation of CMC sections. Hosted all
regulatory inspections: FDA, MCA & EMEA. Biologics & parenteral drug
products (21CFR; Parts 11, 210, 211; ICH Q1 - Q10; and Eudralex Volume 4)
compliance.
SERONO LABORATORIES, INC., Randolph, MA; July 1990 - February 1997.
QC Microbiology Supervisor: QA/QC - Hired as Senior Microbiologist in 1990
and promoted to Supervisor in 1992. Responsible for day-to-day operations
of the microbiology lab and supported QA and Manufacturing operations
related to Cell Culture derived recombinant human growth hormones (rHGH) in
collaboration with Purchasing, Sales, Marketing, Manufacturing,
Warehousing /Logistics, IT, Finance and Legal departments. Supported all
start-up and pilot plant production of products including Technology
Transfers. Provided support in the review and preparation of CMC sections.
Hosted all regulatory inspections: FDA, MHRA & EMEA. API, biologics,
monoclonal antibodies, parenteral drug products (21 CFR; Parts 11, 210,
211; ICH Q7 - Q10); Eudralex Volume 4. Roller bottle, bioreactor
fermentation, lyophilization, and robotics technology compliance.
MURO PHARMACEUTICAL, INC., Tewksbury, MA; May 1986 - June 1990.
QC Microbiology Supervisor: QA/QC - Supervised the day-to-day functioning
of the microbiology lab and supported QA and manufacturing operations for
all drug production activities. Hosted FDA inspections. Rx/OTC,
solid doses, API, and ophthalmic products (21CFR; Parts 11, 210, 211; ICH
Q7 - Q10; 21CFR; Part 820, ISO 9001-2000 & 13485-2003 and Eudralex Volume
4) compliance. Supported and participated in ATF and DEA inspections.
DOUGLAS AUTOMATED LABORATORIES, Sydney, Australia; August
1984 - April 1986.
Clinical Microbiologist: QA/QC - Conducted routine
diagnostic clinical laboratory work in microbiology,
chemistry, serology, mycology, blood chemistry
cytology/histology.
John K. John
Page 3
SKILLS Operation of GC; Met-One & Climet particle counters; RCS Plus &
RCS High Flow units; SMA & STA; Microbial identification
systems (API, Vitek & MIDI); Isolators; Steritest units,
HPLC, GC, FTIR, Osmometer, Autotitrator,
Spectrophotometer.
COMPUTER MS Office (Word, Excel, Access, PowerPoint), MS Project,
Designer, CC Plus, AS-400,
SKILLS Prism, Paintbrush, SAP, Visio, LIMS, Catsweb, Documentum, EtQ,
Pilgrim, TrackWise.
GLOBAL AUDIT
EXPERIENCE
. NRC, Department of Health (Commonwealth of
Massachusetts), USA
. USDA & USFDA/CBER & CDER, USA
. MCA/MHRA, United Kingdom
. EMEA, Germany
. TUV, Annual ISO 9001 &13485-2003 Certification, CE
Marking
. DNV, ISO 13485-2003 Initial visit &Certification,Norway
. TGA, Australia
. Government of Taiwan, Department of Health, Taiwan
. CLIA, NY & other State and Federal inspections, USA
. GxP inspections from major domestic and international
biopharmaceutical companies, Global
PRESENTATIONS
Hosted Quality Management Reviews (QMRs) every quarter at Cook Pharmica LLC
for 2009 - 2011.
Annual cGxP & ISO training (Cook Pharmica LLC); 2009 - 2011
Annual cGxP, ISO, & Validation training (Cogenics, Inc.); 2007 & 2008.
. Aseptic processing/techniques training with industry
consultants Ann Marie Dixon and Jim Akers related to
audit findings of fill room practices and mold
investigation (Alcon Laboratories); 2002
Environmental & Water monitoring program at BASF for D2E7 (IND) Launch
Capacity FDA Type C meeting (FDA, CBER, Rockville, Maryland); 2000
Technical Course "Topics in Microbiology" (BASF Bioresearch Corporation);
2000.
Clean Rooms, Clean Room Behavior & Contamination Control (BASF Bioresearch
Corporation.); 1999
Clean Rooms, Clean Room Behavior & Contamination Control (Biopure
Corporation.); 1998
Clean Rooms, Clean Room Behavior & Contamination Control (Serono
Laboratories, Inc.); 1991, 1995, 1996.
Environmental Monitoring of Clean Rooms (Crosspoint Engineering, Raytheon,
Cambridge, MA); 1995.
AWARDS Awarded the 2002 third quarter and the 2002 year merit awards
for Continuous Improvement Program (CIP) at Alcon
Laboratories.
EDUCATION UNIVERSITY OF BRIDGEPORT
Bridgeport, CT
Master of Science degree in Microbiology, August, 1986.
UNIVERSITY OF BOMBAY
Bombay, India
Bachelor of Science degree in Microbiology, May 1978.
Minor: Chemistry.
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