Biopharmaceutical Consultant Contract
Resume:
James Thiebeau
***** **** **. ********* ** *****
********@*****.***
SUMMARY OF CAPABILITIES
20+ years-experience in Bio-Pharmaceutical & Laboratory Ops including communications with regulatory authorities
SME in Process, Method, Equipment, Facilities, Utilities, Instrument and Cleaning Validation Lifecycle Management, Risk Assessments/ Impact Assessments.
Process Development/Tech Transfer SME. Proven record of success collaborating to achieve commercial product launches
Lead process map development for global strategic projects to support new product introduction and network capability
Specialized in upstream, recovery, and downstream OPS in mammalian, baculovirus and bacterial expression systems
Ability to lead unit operations, motivate staff and elevate performance & compliance metrics within a team or department
Expert in; Manufacturing, Validation., Engineering and QA/QS for sterile and aseptic commercial manufacturing
Diversified in Quality Systems; FDA 21 CFR210 &211, 820 & 1271, ISO9001:2015, 13485 and ICH/ QBD Quality Guidelines
Expert in Lab functions deviation/ investigation management, change control, RCA & CAPA, DMS and LIMS systems; microbiological, bioanalytical, laboratory environmental testing &sterility testing under FDA control.
January 2025-Present Validation - Quality Assurance Consultant
Technical Services (contract) Agilent NSAD Nucleic Acid Solutions Division. Nonconformance investigator supporting both Frederick and Boulder oligonucleotide-based drug substance development and manufacturing with knowledge of nucleic acid synthesis, purification, ultrafiltration, annealing and lyophilization techniques and equipment.
2018 – 2023 Principal Validation-Engineering-Quality Assurance Consultant
Final QA approver for Engineering and Validation at start-up CDMO biotechnology facility focused on manufacture of mammalian and microbial-based therapeutic proteins. Provided support for site start-up of two stainless steel 20K reactor trains, all upstream, recovery, downstream, warehousing and shipping. Followed by facility utility and equipment fit CQV for one client with one molecule and a second client with two molecules. Activities included CSV/CSQ, equipment, facilities and utilities CQV, CIP and SIP PQ, EMPQ, Validation and Engineering risk and impact assessments, and Manufacturing, Engineering and Validation major/critical deviations and change controls. (AGC Biologics, Boulder CO)
Transition sample management group with implementation from legacy QC system to LIMS. (Avexis/ Norvartis)
Principal Process Engineering Consultant plant/process transfer for new nucleic acid technology site in Cape Town South Africa. Process characterization and optimization, equipment, instrument, utility, and facility design. New site located in the western cape for future expansion and scale up of existing South Africa manufacturing operation. (Legacy Roche)
2016 – 2018 QA/QS Commercial (CDMO) Product Release Corden Pharma Colorado
Head of Corden Pharma’s QA commercial product portfolio responsible for batch release of all API produced at the site. Responsible for 8 commercial product lines within peptide and high-potent small molecule platforms. QA and Validation oversight on 3 commercial product launches, including Ironwood Pharmaceuticals, Linaclotide and AbbVie, Elagolix.
QA and Validation Oversight for process, computer, equipment, and capex (2 new aseptic suites) TFF and Chrom.
Investigation/ deviation system owner. Developed and implemented new investigation process and SOPs resulting in >65% decrease in deviations for the site and increased plant efficiencies (MBR review, batch release cycle times etc.). Review and approve all deviations, investigations, CAPA, RCA, FMEA and effectiveness checks for commercial product.
Client POC and decision maker for Quality Agreements, MBR packages, Audit deliverables, reportable deviation investigations, major schedule impacts and compliance readiness, NPI new product introduction
Responsible for approval of master batch record package (batch record, process manual, change control, specs, (methods and labels) and authored all CoA for commercial product. Manage all customer notifications, approvals, and Quality Agreements for all commercial products. Responsible for all customer complaints, vendor deviations and supplier issues impacting commercial products and all associated components or raw materials.
Quality Lead of stability surveillance programs for all commercial products. Quality Lead for all process, computer, equipment and capex change control, validation, and risk assessments. Author Quality Manual and Site Master Plan. Lead or participated in over 50 audits. Author APRs for all commercial products. Six-sigma lean leader certified.
2010 – 2016 Pharmaceutical Consultant Various Engagements
Validation Engineer, Hospira/Pfizer, Boulder CO – Validation engineering – CSQ/CSV, spreadsheet remediation, PQE system remediation and reporting, PPQ and CPV support, protocol and final report writing, CAPA, risk assessments and change control.
Process Validation, Arkema, Memphis TN. Legacy DuPont plant cited for inadequate validation. 483 response team-lead reporting to Director of Quality. Responsible for validating semi-automated hydrogen peroxide production process controlled by DCS (distributed control system) system.
Process Validation Hospira Boulder CO – Managed team of 7 responsible for gap analysis and technical report detailing process validation status of site API portfolio. 483 response team-lead reporting directly to corporate Manager of Validation.
Writer/Reviewer Parenteral Manufacturing Deviations Hospira McPherson KS. Part of team working on high-level DP & DS investigations involving FMEA, risk analysis, CAPAs and change control systems.
QA System Remediation, Field Complaint Investigations, Parenteral Manufacturing – Hospira, Rocky Mount NC. 483 response team-member responsible for high-level DP field complaints (FAR) field alert reporting and quality system remediation pertaining to site FAR procedures. Also worked on legacy mid to high-level parenteral manufacturing deviations/ investigations involving FMEA, risk analysis, CAPAs and change control ancillary systems, and remediation of quality system procedures governing the process and procedures for both DP and manufacturing.
2009 - 2010 Laboratory Manager OPX Bioproducts
Design-build fermentation systems for upstream, recovery and downstream production, and analytical, molecular biology & biochemistry groups. Designed, built, installed and managed systems for EH&S and supply chain. Managed facility and utility upgrades, including biometric access installation in conjunction with computer network upgrade. Oversee equipment & instrumentation installs and metrology (PM/ calibration) program. Responsible for all lab SOPs including viral vector, micro, analytical, reagent & media prep, and MSDS requirements.
2006 – 2008 Pharmaceutical Consultant Various Engagements
Quality Engineer -Designed CAPA system for effective Quality Systems management streamlining batch record release. Improved change control system and document control procedures providing product backlog remediation for multi-year backlog of deviations. (Allosource)
Laboratory Manager - Performed micro, chemical and physical testing for medial food product derived from bovine blood. Participated in obtaining GRAS designation from FDA. Responsible for all raw material release testing, in-process testing, and final product & retain sample testing. (Colorado Biolabs)
Pharmaceutical Validation engineer - Performed cleaning validation in support of Kepivance (palifermin), Kinaret & Denosumab (Prolia®) launch. Protocol development/verification & cycle development on various pieces of equipment and skidded components in licensed cGMP mammalian manufacturing environment. (Amgen)
Performed gap analysis on NDA production package for P3 antibiotic. Participated in drafting brief for CMC section of pre–NDA filing to FDA for type–B meeting with CBER, US Dept of HHS. (PAR Pharmaceuticals)
2004 – 2007 Process Development Eppendorf 5–Prime/Qiagen
Reporting to VP of Mfg. with dotted-line reporting to VP, R&D. Responsible for tech transfer of several nucleic acid and enzyme/ antibody processes from R&D to Manufacturing. Increased revenues >20MM USD across several campaigns. Achieved significant COGS reduction for all legacy biological component production processes. Headed tech transfer and integration to biological operations site for Qiagen in Hilden Germany during company acquisition. Decommissioned Colorado plant and equipment and managed equipment and instrument brokerage.
2002 – 2004 Manufacturing Supervisor Merck & CO Inc.
Sterile and aseptic commercial (3000L )scale for 100 plus SKUs. Adjusted shift schedules improving throughput and efficiency. Participated in several shut–down campaigns involving class 10 (ISO Class 4) clean room CAPEX projects and validation studies or projects. Headed departmental EM activities including implementation of Oracle–based LIMS providing compliance with FDA CFR Title 21 Part 11.200 for electronic signature. Conducted CAPA and RCA deviation investigations and assisted in validation studies involving process and equipment improvement. Managed PM Cal requirements and shop floor audits for the QA Department. Participated in FDA compliance, internal and external customer audits.
Quality Analytical Technician – Performed QC release testing for Merck’s global live and recombinant vaccine portfolio, achieving 100% on–time results for world-wide live and attenuated virus vaccine supply. Participated in QC validation of ProQuad®. Lead OOS, CAPA & RCA laboratory investigations. Compiled complex data from multiple sources for presentation to management and regulatory filing (Alzheimer’s).
2002 Scientist Contract Engagement
Downstream (chrom., UFDF, TFF) and upstream/ recovery process characterization of protein therapeutics and processes, analytical method development and transfer for a monoclonal antibody of a phase 3 diagnostic that subsequently successfully achieved FDA approval. Transferred methods from pilot scale into manufacturing and trained staff on assay for product release. (Immunicon)
2001 Technical Associate Lampire Biological Labs
Improved client satisfaction & project success using effective upfront analysis and customer interaction. Compiled and analyzed complex data from multiple sources for presentation to various clients. Consulted with key clients resulting in contracts awarded to produce materials worth in excess of 20M USD. Developed commercial cGMP mAb & cell–line manufacturing processes.
2000 Biochemist Contract Engagement
Developed peptide characterization and purification assay method involving reverse-phase HPLC. Promoted to bioprocessing role. Developed purification process for extremely difficult membranous protein from mammalian tissue culture resulting in JCBR published paper. Supplied enzymes to Merck’s Alzheimer’s drug discovery group. Performed bench-scale and pilot scale purification studies to determine and recommend normal operating ranges and proven acceptable ranges in support of critical process parameter determination for commercial control strategy. Conducted process monitoring, campaign summary reports and annual product reviews. Honed my process development/engineering abilities, including complex data presentation skills to senior staff, design-build downstream processing systems, including chromatography skid, and large scale reagent/ buffer prep and handling including TFF/ UFDF skids. (Merck Research Labs, MSAT)
1998 –2000 Research Associate Thomas Jefferson University
Member of Baruch S. Blumberg’s (1976 Nobel Laureate for Medicine) team. Worked at Oxford University, United Kingdom. 1st Beta tester for Perkin Elmer’s first real–time q–PCR platform; Taqman®. Developed novel techniques for in–vitro detection of hepatitis B. Routinely compiled and analyzed complex data from multiple sources, including scientific literature, for presentation to management. Participated in monthly presentations from scientific journals to PhD scientists (Journal Club).
University of Delaware 1997 - Bachelors- Biological Sciences, with an emphasis on; Immunology, Genetics & Biochemistry
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