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Benjamin R. Wade, M.B.A.
600 E. Erie | Albion, MI | 49224
(517) 945-3735
brexwade@gmail.com
QUALIFICATIONS
 Experienced leader with over 15 years of cGMP Quality experience
 Managed up to 15 direct reports from high school graduates to Ph.D. chemists
 ASQ Bronze Certification Exam, Lean Knowledge Certificate, and Lean experience
including 5S implementation and Kaizen
 Experienced with FDA interaction and communication including audits, meetings
(phone and face-to-face) and handling of 483 observation responsibilities
 Project leadership including method development and optimization,
implementation and validation of analytical instruments and test methods, test
method transfer, and continuous improvement projects
 Extensive technical writing experience writing including protocols, procedures,
change controls, deviations, and corrective/preventative actions
 Extensive experience with United States Pharmacopeia, Food Chemicals Codex,
American Chemical Society Handbook and European compendia
 Performed GMP lab audits of suppliers, domestic and international (Germany)
EMPLOYMENT HISTORY
Albion Malleable Brewing Co, LLC
Albion, MI
March 2016 – Present Founder, Chief Brewing Officer (C.B.O.)
Business Co-founder with direct involvement in all aspects of launch, including
structure and planning, finance and marketing. CBO responsibilities include
member/manager oversight of the business and the design, planning, sourcing and
oversight of brewery operations and production. Planned open date in early 2018.
Emergent BioSolutions
Lansing, MI
June2011 – October2016 Manager/Supervisor – Quality Control
Leader of two teams – QC Chemistry (Operations) and QC Methods (Validation).
Managed and coordinated QC activities including daily testing, continuous
improvement (Lean implementation), validation of methods and instruments
qualification, CAPAs and Change Controls, and deviation/investigation support.
Achievements include:
 Reduction of average sample testing lead time by more than 50%
 Lead Lean initiatives to improve raw material testing program and streamline
the laboratory investigation and invalid assay documentation processes
 Key involvement in a major failure mode investigation, including method
validation and successful submission which reduced the failure mode from
30% to less than 3%
 Led employee development, coaching and leadership for up to 15 direct
reports. Hired and coached two supervisors who were promoted into
management positions.
 Managed department budget of approximately $2.5m, including resource
allocation, CAPEX, and modeling
2008-June2011 Scientist - QC Analytical Methods Section, Emergent
BioSolutions
Performed activities for QC Analytical Methods including qualification, validation, and
transfer activities. Oversaw projects through their lifecycle from development, study
execution, support of regulatory affairs submission, and implementation through
change control and quality systems. Accomplishments include:
 Awarded the 2009 Excellence Award – Emergent’s highest recognition
 Supported successful extension of BioThrax® expiration dating from 3 to 4
years. This included authoring 12 validation documents, working with
employees across multiple sites and departments, and managing contracts
and services with external companies. The success of this project was valued
at over $320 million.
 Successful test method transfer of assays to contract testing facilities
 Created and implemented a raw material testing improvement plan
 Authored FDA approved reports for proposed product specification changes
 Participated in FDA audits including interviews and management of company
responses to observations
 Assisted Regulatory Affairs in German licensure submission and worked on
the transfer of QC assays
2002-2008 Progressive Positions - Associate/Senior Scientist,
Quality Control Product Testing- Emergent BioSolutions
 Extensive cGMP testing experience including raw material and product release
testing of BioThrax
 Extensive technical writing experience including SOPs, technical studies,
change controls, CAPAs and deviations
 Testing including wet chemistry, FTIR, UV-Vis, GC, SDS-PAGE, titrimetry, and
HPLC
Pharmacia Corporation
Kalamazoo, MI
2001-2002 Analytical Laboratory Technician
 Carried out raw material and in-process analytical testing including titrimetry,
TLC, optical rotation, IR spectroscopy, and particle size analysis.
 Participated in internal safety and compliance audits for laboratories.
 Reviewed and approved laboratory records and LIMS data entry
BioPort Corporation
Lansing, MI
2000-2001 QC Laboratory Technician,
 Carried out a variety of QA/QC responsibilities for the Microbiology, Bioassay,
and BioAnalytical laboratories
 Assisted with anthrax potency testing, routine sampling and testing of water
for injection (WFI) and clean compressed air (CCA) systems, and
environmental monitoring
EDUCATION
 Masters of Business Administration – Spring Arbor University
 B.A., Biology – Albion College
 Professional training through course attendance in the areas of method
validation, cGMP compliance, raw materials and analytical instruments
 Lean training including ASQ Bronze exam and Emergent certification with the
Demmer Center at Michigan State University

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Ben Wade 2017 Resume

  • 1. Benjamin R. Wade, M.B.A. 600 E. Erie | Albion, MI | 49224 (517) 945-3735 brexwade@gmail.com QUALIFICATIONS  Experienced leader with over 15 years of cGMP Quality experience  Managed up to 15 direct reports from high school graduates to Ph.D. chemists  ASQ Bronze Certification Exam, Lean Knowledge Certificate, and Lean experience including 5S implementation and Kaizen  Experienced with FDA interaction and communication including audits, meetings (phone and face-to-face) and handling of 483 observation responsibilities  Project leadership including method development and optimization, implementation and validation of analytical instruments and test methods, test method transfer, and continuous improvement projects  Extensive technical writing experience writing including protocols, procedures, change controls, deviations, and corrective/preventative actions  Extensive experience with United States Pharmacopeia, Food Chemicals Codex, American Chemical Society Handbook and European compendia  Performed GMP lab audits of suppliers, domestic and international (Germany) EMPLOYMENT HISTORY Albion Malleable Brewing Co, LLC Albion, MI March 2016 – Present Founder, Chief Brewing Officer (C.B.O.) Business Co-founder with direct involvement in all aspects of launch, including structure and planning, finance and marketing. CBO responsibilities include member/manager oversight of the business and the design, planning, sourcing and oversight of brewery operations and production. Planned open date in early 2018. Emergent BioSolutions Lansing, MI June2011 – October2016 Manager/Supervisor – Quality Control Leader of two teams – QC Chemistry (Operations) and QC Methods (Validation). Managed and coordinated QC activities including daily testing, continuous improvement (Lean implementation), validation of methods and instruments qualification, CAPAs and Change Controls, and deviation/investigation support. Achievements include:  Reduction of average sample testing lead time by more than 50%  Lead Lean initiatives to improve raw material testing program and streamline the laboratory investigation and invalid assay documentation processes  Key involvement in a major failure mode investigation, including method validation and successful submission which reduced the failure mode from 30% to less than 3%  Led employee development, coaching and leadership for up to 15 direct reports. Hired and coached two supervisors who were promoted into management positions.  Managed department budget of approximately $2.5m, including resource allocation, CAPEX, and modeling
  • 2. 2008-June2011 Scientist - QC Analytical Methods Section, Emergent BioSolutions Performed activities for QC Analytical Methods including qualification, validation, and transfer activities. Oversaw projects through their lifecycle from development, study execution, support of regulatory affairs submission, and implementation through change control and quality systems. Accomplishments include:  Awarded the 2009 Excellence Award – Emergent’s highest recognition  Supported successful extension of BioThrax® expiration dating from 3 to 4 years. This included authoring 12 validation documents, working with employees across multiple sites and departments, and managing contracts and services with external companies. The success of this project was valued at over $320 million.  Successful test method transfer of assays to contract testing facilities  Created and implemented a raw material testing improvement plan  Authored FDA approved reports for proposed product specification changes  Participated in FDA audits including interviews and management of company responses to observations  Assisted Regulatory Affairs in German licensure submission and worked on the transfer of QC assays 2002-2008 Progressive Positions - Associate/Senior Scientist, Quality Control Product Testing- Emergent BioSolutions  Extensive cGMP testing experience including raw material and product release testing of BioThrax  Extensive technical writing experience including SOPs, technical studies, change controls, CAPAs and deviations  Testing including wet chemistry, FTIR, UV-Vis, GC, SDS-PAGE, titrimetry, and HPLC Pharmacia Corporation Kalamazoo, MI 2001-2002 Analytical Laboratory Technician  Carried out raw material and in-process analytical testing including titrimetry, TLC, optical rotation, IR spectroscopy, and particle size analysis.  Participated in internal safety and compliance audits for laboratories.  Reviewed and approved laboratory records and LIMS data entry BioPort Corporation Lansing, MI 2000-2001 QC Laboratory Technician,  Carried out a variety of QA/QC responsibilities for the Microbiology, Bioassay, and BioAnalytical laboratories  Assisted with anthrax potency testing, routine sampling and testing of water for injection (WFI) and clean compressed air (CCA) systems, and environmental monitoring EDUCATION  Masters of Business Administration – Spring Arbor University  B.A., Biology – Albion College  Professional training through course attendance in the areas of method validation, cGMP compliance, raw materials and analytical instruments  Lean training including ASQ Bronze exam and Emergent certification with the
  • 3. Demmer Center at Michigan State University