Kenneth George Bosley Jr.

Phone (860) 689-3035

Email: ken_bosley1@yahoo.com Linked in URL: https://www.linkedin.com/pub/kenneth-bosley/101/26b/278

PROFESSIONAL SUMMARY

Quality Control professional with 12 years of experience within GMP biotech manufacturing facilities adhering to cGMP guidelines, ICH Q2, Q7, Q9 and Q10. Specialty areas include microbiology, immuno-biology and physical chemistry.

Skills 6 Sigma Organization and 5S SoftMax Pro Cell Culture SmartLab

Bioburden MODA ELISA SM-LIMS/Thermo LIMS Kinetic Endotoxin (KQCL) Trackwise

BiaCore-Concentration Analysis Maximo Bioassay-Apoptotic and Potency JMP Software Water system testing (TOC, Endo, Conductivity) MS Word/Excel/Power Point

RNA/DNA Analysis via Fluorescence CAPA SDS-PAGE Gels Action/Alert Limit Investigation Cell Viability OOS/OOT Investigation

Culture Purity Deviation initiation and investigation Environmental Monitoring and Trending (Surface, Air, Water)

Agilent GC

Change Control Chromeleon HPLC Software

Current Work Experience Cardinal Health, E. Hartford CT October 2016-Current Area Manager (PET Manufacturing Operations)

Coordinate and oversee two manufacturing PET sites with $3 Million revenue between the two sites.

Trouble shoot analytical data

Review/Approve validation documentation

Review/Approve Deviations, Change Control and CAPA documentation

Work cross functionally between PET manufacturing and the receiving pharmacies to identify gaps and strengthen efficiencies.

Represent PET Operations in Corporate and agency audits

Responsible for audit responses in a timely manner and for the implementation of such CA’s to audit findings

Compile monthly financial and production reports LFB USA, Charlton MA November 2015-October 2016

QC Manager (Microbiology & Raw Materials)

Manage day to day in-process testing, environmental monitoring and water system testing

Manage day to day incoming raw material release and full lot testing both in house and external sample testing by contract testing laboratories

Represent Quality Control Microbiology and Raw Materials during agency (FDA/EMA/Health Canada) and internal corporate audits

Develop direct reports technical expertise and compliance understanding

Oversee both Micro and Raw Materials departments with 5 direct reports

Complete Monthly departmental metric reports, focusing on testing output, on time turn around, quality system initiation and on time close out or records as well as individual contributions

Collaborate with CMO Microbiology laboratory operations (Troubleshooting and investigation sign off)

Initiate all forms of quality systems (CAPA/Change Control Deviations)

Compile and present Environmental Trending reports

Collaborate in multi-departmental meetings for manufacturing commissioning post construction and implementation of HVAC and new water system (USP) IOPQ.

Implement continuous improvement activities through the use of “Dashboards”

Ensure audit readiness for PAI inspection.

Chair Raw Material Review Board for classification of raw material criticality and follow up on supplier qualification

Perform risk analysis using fishbone diagrams, process FMEA or other risk analysis tools as necessary.

Shire HGT, Lexington MA April-2015-November 2015 QA Specialist II QC Lab Oversight (Contractor)

Deviation L-1 review and approval

CAPA and Change control review and approval

Stability support including stability protocols and reports review, LIMS Built approval, trending stability report

review,

Laboratory Operations support (e.g data spot check audit, assay observation, lab walk through, reagent program

oversight)

QC SOP review and approval

Raw Material specification review and approval

Perform daily tasks for TrackWise query, document archiving, coordinate departmental ordering

Amgen Inc., Woburn, MA May 2014-March 2015 Sr QC Analyst (Contractor)

Planned daily work schedules

Represented QC Analytical at audits and internal meetings

Initiated and assessed quality records such as OOS, CAPA, OOT and Non-Conformances and Change Control

Reviewed lab assay data

Contributed to the implementation and validation of an SM-LIMS system.

Supplied the lab with training hands on and road-show presentations.

Worked to convert the present lab which was clinical to a cGMP commercial support QC Lab.

Lonza Biologics Inc., Hopkinton, MA February 2011-March 2014 QC Microbiology Supervisor of Product testing and Environmental Monitoring

Supervisor 5 direct reports of various experience levels

Developed direct reports via 1 on 1s and external trainings

Detailed outlines for progress and improvement for analysts

Performed mid-year and end of year evaluations to give analysts feedback both positive and constructive.

Addressed concerns by direct reports and resolved conflicts as they arise through counseling and disciplinary actions.

Experience in hiring new analysts for the lab, selecting the best talent to give the group maximum effectiveness.

Represented QC Micro at site leadership team meetings and other various high level interactions.

Organized assets with Validation, QA, QC systems groups and Manufacturing (Upstream and Downstream) to meet project timelines. (Cleaning Validations Etc)

Performed all laboratory testing including but not limited to: ELISA, Bioburden, Endotoxin, DNA/RNA residual analysis, Bioassay.

Trained new and lower level analysts on appropriate assays as needed and based upon their training criteria.

Scheduled product testing from multiple suites and multiple products manufactured simultaneously to ensure swift turnaround of data

Working knowledge of cGMP/USP/EP guidelines.

Participated in agency audits (FDA/EMA), corporate and customer audits

Initiating and authoring lab investigations (OOS, CAPA, OOT)

Assessed Deviations, Change Controls, CAPAs and Microbial contamination reports Previous Work Experience

Pfizer, Groton, CT, November 2010 to February 2011 Research Associate (Contractor)

Bristol Myers Squibb, Devens, MA June 2009-November 2010 Sr Quality Control Specialist

Genzyme Corp., Framingham, Massachusetts February 2008-June2009 Quality Control Analyst II

Amgen Inc., West Greenwich, Rhode Island March 2006- October 2007 Senior Quality Control Associate

EDUCATION MS Biotechnology,

University of Connecticut 2002-2004 BS Biology,

Southern Connecticut State University 1998-2002