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