Brian Pickering has over 15 years of experience in microbiology quality control and assurance roles within the biologics manufacturing industry. His experience includes establishing environmental and raw materials monitoring programs, training personnel, managing microbiology laboratories, ensuring compliance with regulations, and representing companies in regulatory audits and responses. He currently serves as the QC Raw Materials Microbiology Manager at Sanofi Genzyme in Northborough, MA where he manages various microbiology and contamination control programs.

1. Shrewsbury, Massachusetts Phone (617)-817-2309
E-mail
brian.pickering@genzyme.com
pickering.bw@gmail.com
BrianPickering
Professional
Experience
2012 – Present Sanofi Genzyme Northborough, MA
QC Raw Materials Microbiology Manager
• Established and currently manage controlled-classified raw material sampling program with
design, construction/ qualification of 2,000 sq. ft. clean space and development of contamination
control program including the governing SOPs, quality systems, and training curricula.
• Established and currently manage risk based site environmental monitoring and critical utilities
monitoring programs.
• Established site microbiology awareness and “Microbiology for the Non-microbiologist” training.
• Ensure continued compliance of raw material microbiological specifications to applicable
pharmacopeia (USP, EP, JP, ChP).
• Established on-site rapid endotoxin testing program (Endosafe) for raw materials.
• Consolidated qualification of all biologics network QC microbiological media and biological
indicators adding extensive cost and process efficiencies.
• Represent site in regulatory audits (FDA, EMA, TGA, TMOH, ANVISA, etc.) and related regulatory
responses.
• Microbiology and contamination control SME for network COPs, OOS/ contamination
investigations, and cross-functional planning.
• Microbiology liaison to Facilities Group to ensure continued performance and compliance of
HVAC, critical utility, and EMS/BMS systems.
• FMEA and HACCP-trained risk facilitator working transversally with and assessing risk for various
functions across the biologics manufacturing network.
• Collaborate with biologics manufacturing network in closure of consent decree work plan
components.
• Manage cross-functional team of senior microbiologists and operations support personnel.
• Represent firm at array of microbiology related professional organization meetings (PDA, ASM,
IUMS, etc.) in assurance of continued compliance and improvement.
2009 – 2012 Genzyme Corp. Allston, MA
QC Microbiology Supervisor (1st
and 2nd
shifts)
• Managed all 1st
and 2nd shift QC Microbiology laboratory activities.
• Managed 10 full time reports; maintain training schedules; provided written performance
appraisals; and develop clear SMART goals to meet personal development and business needs.
• Provided timely quality results to facilitate manufacturing, intermediates and product release, as
well as stability/ sterility testing of final product.
• Collaborated with Training group in multiple cross-functional training initiatives including Aseptic
process training for manufacturing associates.
• Managed highly dynamic schedule for up to 40 contributors’ daily activities across all shifts.
• Oversaw remediation of plant Vesivirus contamination with close coordination of BI and EM
testing with VHP decontamination activities.
• Participated in vetting and selection of new network-wide LIMS systems (StarLIMS).
• Collaborated with HR business partners to develop employee performance improvement plans.

2. 2006 – 2009 Genzyme corp. Allston, MA
QC Microbiology Analyst II
• Led extensive Sterility program utilizing isolator and VHP system. Responsible for Sterility testing of all
Finished Product as well as training and supervision of five analysts.
• Collaborated with validation personnel in extensive qualification of VHP decontamination and isolator
system.
• Coordinated successful preparation for audits by FDA, MHRA, IMB.
• Performed environmental monitoring of class 10k and class 100 cleanroom areas and collection of
water and clean steam sites.
• Performed various assays: Bradford protein, Kinetic and Gel Clot Endotoxin, Bioburden and Sterility for
all products, raw materials and intermediates.
• Authored and revised SOPs.
• Responsible for ordering and stock of lab supplies.
• Performed trending, troubleshooting, and investigations of lab related issues.
• Performed training of and mentored incoming analyst and cross-functional employees.
• Led validation of rapid microbial detection systems.
• Entrusted as high-profile sterility function lead.
2002 - 2006 Organogenesis Inc. Canton, MA
Canton, MA
QCMicrobiologistII/Histologist
• Performed environmental monitoring of class 10k and class 100 cleanroom areas.
• Responsible for sterility assurance of living skin substitute, all associated raw materials and water
systems; sterility, bioburden, and endotoxin testing.
• Authored and revised SOPs pertaining to Quality functions.
• Monitored and validated all personnel, environments, and methods pertaining to product.
• Carried out all Histological functions related to release of product for sale.
• Assisted in auditing procedure and enacted cross-functional training.
• Trained all new Quality staff.
• Familiar with cGMP, USP, and FDA regulations.
• Streamlined QC group and methods; drastically decreased group expenditure.
Education
2000 - 2002 Organogenesis Inc. Canton, MA
SolutionsChemistry/ProductionSupport
• Aseptically prepared solutions (hormonal, etc.) for manufacture of living skin substitute.
• Team leader of 7-man lab support crew assuring strict adherence to SOPs, cGMPs, GLPs, and FDA
guidelines.
UMASS Boston Boston, MA
Biology/Earth&GeographicSciences
MBCC Wellesley, MA
Marine Biotechnology
Skills Cleanroom construction| Environmental qualification| HVAC| EMS/BMS| EM/CU| Disinfection efficacy|
EM/CU trending| Method validation/ verification| Endotoxin analysis| Bioburden analysis| Growth
promotion| Rapid systems and emerging technology| SOP/ OJT authoring| Training/ mentoring| Aseptic
technique| Risk analysis| Regulatory audits| Pharmacopeia compliance| Change control| OOS
investigation| CAPA| Laboratory management| USP <85><61><62><1116><797>| Technical writing|

3. Consent Decree| Etc.