Benjamin R. Wade, M.B.A.

600 E. Erie | Albion, MI | 49224

(517) 945-3735brexwade@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, LLCAlbion, MIMarch 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 BioSolutionsLansing, MIJune2011 – 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 CorporationKalamazoo, MI2001-2002 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 CorporationLansing, MI2000-2001 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