Kevin D. Bond
Stem,NC
Summary
Experienced people leader with over 20 years of experience working in a cGMP/GLP environment. Excellent skills in Environmental Monitoring and Microbiological testing for the pharmaceutical industry (Sterility, BET, Micro ID, etc). Highly trained senior QA associate, skilled in investigations/tools (5 "Whys", Pareto Analysis, Process Mapping, FMEA) and CAPA development, internal auditing and various validation activities.
Overview
22
22
years of professional experience
Work History
Site Manager
Boston Analytical
06.2021 - Current
- Set up of all operations for Boston Analytical’s first laboratory in RTP (Facilities Monitoring)
- Personnel hiring, management and training
- Equipment/instrument qualification and calibration
- Method transfer of microbiological and environmental monitoring methodologies
- Review and execution of microbiological and environmental monitoring projects
- Assist sales team with client/project management
- Management of safety and hazardous waste procedures
Environmental Monitoring and Raw Materials Supervisor
Catalent
12.2017 - 06.2021
- Develop and execute laboratory work plans/schedules for self and team that meet customer milestones and deadlines
- Trains, coaches and mentors team members and others on technical skills and career development
- Accountable to maintain laboratory housekeeping compliance
- Responsible to supervise team in day-to-day execution of work assignments
- Accountable for instrument autonomous maintenance, uptime and requesting instrument refresh
- Identifies and drives department level improvements, removing simple barriers and escalating recurring barriers
- Supports audits and investigations for work performed by team
- May review technical documents for accuracy, thoroughness and regulatory compliance
- All other duties as assigned
Quality Operations Business Leader
Procter & Gamble
02.2014 - 12.2017
- Oversight of all Quality Operations activities including supervision of Quality Operations Partners (4 direct reports):
- Deviation/OOS investigation – investigation of non-conformance with site operating procedures
- QA on the floor activities – real time decision making on product quality issues
- CAPA – Corrective and Preventive Action development to prevent recurrence of quality issues
- Customer Complaints – process incoming customer complaints from corporate
- Internal/External Audit Support (FDA/Regulatory)
- Key User for site eQMS (TrackWise)
- Managed access and training for all site TrackWise users
Quality Systems Specialist II
Ben Venue Laboratories (Boehringer – Ingelheim)
08.2011 - 01.2014
- Provide quality oversight for CAPA, change control and investigation of events which includes: event classification, risk/impact assessment and product disposition
- Conducts stage II (manufacturing) Out of Specification (OOS) investigations utilizing investigational tools such as 5 Why’s, Fishbone diagrams, Process Maps, Brainstorming, Pareto analysis, etc
- Training/Development of Quality Investigators
- Participates in the Investigator Training program
- Support of regulatory and client inspections/audits
Research Biologist/Quality Engineer
Covidien / Mallinckrodt
11.2005 - 08.2011
- Coordinator – 5 years coordinating Bacterial Endotoxin Test Lab activities
- Duties include training, validation and routine testing
- Coordinator – 3 years coordinating Process validation Runs (Media Fills) for all production lines
- Primary function is to maintain regulatory compliance regarding sterile/aseptic processing
- Duties Include protocol generation, execution and final reports
- Coordinator – 2 years exception/OOS report investigation for QC Microbiology
- Duties include investigation, tracking and trending
- Method Validation and Implementation of novel microbiological Techniques
- Change Control and SOP development and revision
- Microbial identification (MicroSeq and Vitek2)
- Sterility testing using barrier isolator technology (Direct inoculation and Steritest method)
- Standard QC microbiological testing (Growth promotion, Biological Indicators, Environmental monitoring, etc.)
Associate Microbiologist
BioPort Corporation
05.2003 - 11.2005
- Microbial identification and Growth Promotion
- Microbial analysis of facility water systems
- Product purity testing and Environmental monitoring
- Testing of Biological Indicators treated for sterilization
- Quality control investigation of Out-of-specification results
- Aseptic division of product samples for QC testing (Sterility Testing)
- Bacterial Endotoxin and Total protein testing (Bradford Protein Assay)
- SOP writing, development and revision
Education
Master of Science - Biology with a concentration in Applied and Environmental Microbiology (Alternative Fuel Research)
Central Michigan University
08.2002
Bachelor of Science - Biology (pre-professional/pre-graduate option) with a minor in Chemistry
Central Michigan University
08.1999
Skills
- Technical writing
- Investigation
- Environmental Monitoring
- Various Microbiological Assays (Bioburden, BET, TOC, Conductivity)
Affiliations
- PDA, Parenteral Drug Association
- ASM, American Society for Microbiology
References
Available upon request.
Timeline
Site Manager
Boston Analytical
06.2021 - Current
Environmental Monitoring and Raw Materials Supervisor
Catalent
12.2017 - 06.2021
Quality Operations Business Leader
Procter & Gamble
02.2014 - 12.2017
Quality Systems Specialist II
Ben Venue Laboratories (Boehringer – Ingelheim)
08.2011 - 01.2014
Research Biologist/Quality Engineer
Covidien / Mallinckrodt
11.2005 - 08.2011
Associate Microbiologist
BioPort Corporation
05.2003 - 11.2005
Bachelor of Science - Biology (pre-professional/pre-graduate option) with a minor in Chemistry
Central Michigan University
Master of Science - Biology with a concentration in Applied and Environmental Microbiology (Alternative Fuel Research)
Central Michigan University
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