076

• QC Laboratory Compliance

• Quality System Assessment & Improvement

• Data Integrity Governance

• Data Systems & Computer System Validation (CSV)

• Lab Assessment & Remediation

• OOS, Deviation, Non Conformance, CAPA Program

• Method Development & Validation

• Equipment & Instrument Qualification

• Corporate Training Program

• LIMS Implementation & Document Control
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Industry Consultant      June 2012 – present

Position Summary

• Providing service and support to the Pharmaceutical & Biotechnology industries, including Lab compliance assessment & data integrity remediation, Quality System & Informatics implementation, OOS Process Improvement, cGMP Auditing, and inspection-readiness.   

Examples of projects include:

• Co-lead for 15+ consultants driving Lab Remediation (FDA Commitment) for US sterile facility
• Remediation Lead for Retrospective Review of OOS Investigations. (US & India)
• Data Integrity assessment of Lab Computerized Instruments & process re-engineering of QC Equipment Lifecycle Management program. (EU)
• Technical Project Manager for LIMS implementation of ThermoFisher’s SampleManager® application. (US)

Data Integrity audits, assessment, consultancy (US, EU, Asia)

Position Summary

• Managed Client Relationships and drove Business Development opportunities in the Life Sciences and Training areas.  Acted as lead SME in QA / QC, Validation, and cGMP Training projects.

ASSOCIATE DIRECTOR – Biopharmaceutical Process Sciences                              July 2008 – July 2010

UCB Pharmaceuticals, Inc.                                                                                    (Braine-l’Alleud, Belgium)        

Position Summary

• Responsible for 9 staff members charged with execution of department’s Knowledge Management strategy, including integration of electronic Document Management System (EDMS), LabWare LIMS, Chromatography Data Systems, Process Analytical Technology (PAT) projects, and Lab System upgrades.
• Led Quality/CMC activities within a corporate-wide ‘e-CTD readiness’ team initiative; configuring, validating, and delivering new FirstDoc® EDMS for ~ 800 global users. 

TEAM LEADER / SUPERVISOR / SCIENTIST – Analytical R&S                     March 1989 – Oct 1999

Wyeth Pharmaceuticals, Inc.                                                      (Pearl River, NY & Rouses Point, NY)

Position Summary

• Transitioned from entry-level Chemist at manufacturing facility to Team Leader at R&D site, with responsibilities that included chromatographic and spectroscopic method development/validation, lab automation qualification, drug product testing in support of IND/NDA candidates, process validation, cleaning validation, and clinical release.

Some Achievements include;

• Implemented multiple global Electronic Document Management Systems (EDMS) to prepare company for electronic Regulatory Submissions (i.e. eCTD ready), while representing more than 800 Pharmaceutical Development (CMC), Manufacturing, and Quality end users.
• Led workstream of 10 consultants charged with Retrospective Review of client’s OOS Investigations; formally reviewed 200+ Manufacturing & Lab investigations in less than 4 weeks.
• As Technical Project Manager / Consultant, drove site LIMS implementation of ThermoFisher’s SampleManager® application, including Computer System Configuration & Validation, and User Readiness for ~ 400 users.
• As corporate Program Leader, managed the Lab Information Management System (LIMS) program for 500+ users spread over multiple international sites.
• As Subject Matter Expert, assessed & helped re-engineer Instrument Qualification program as part of a client’s Quality Control Improvement initiative.   Performed deep-dive assessment into Data Integrity issues resulting from Computerized Lab Systems.  Formal recommendations provided.
• Successfully contributed to the QC lab remediation effort at a high-profile, large-volume sterile manufacturer, resulting in successful FDA re-Inspection.  Re-designed QC Training program and implemented 30+ training modules with proficiencies.
• Led successful Technical Transfer of in-licensed capsule & tablet manufacturing processes, requiring 50+ US/EU/ROW Submission updates.  Increased revenue and lowered site cost of goods by adding 100+ SKUs.
• Managed Analytical Development teams who directly contributed to 10+ successful drug approvals.
• Successful interactions with Health Authorities and their related inspections of lab activities under management; e.g. Pre-Approval Inspections, Face-to-Face presentations at FDA Headquarters, no Form 483 observations, etc.
• Created the first Scientific Knowledge Management program within UCB Pharma’s Pharmaceutical Sciences department.