Brian Homan Email & Phone Number

St Louis, Missouri, United States

St. Louis, Mo

• Oversee a team of two GMP operations personnel dedicated to daily laboratory operations, housekeeping and Solutions Preparation for ARD.• Manage a fleet of over 300 GMP instruments and equipment throughout the asset lifecycle. Serve as primary point of contact for Pfizer Digital, Laboratory Instrument Services and Facilities Management partner groups.• Provide operational direction and support to over 200 scientists who utilize the shared GMP lab, including mass communications/trainings for GMP operations at the Chesterfield site.• Lead the 20+ members of the GMP-LOCI team to continuously improve the operational systems in the GMP lab and enforce compliance to GMP principals.• Oversee laboratory compliance upkeep with a focus on maintaining the lab in an audit-ready state. • Represent the GMP lab in audits with internal QA or international government agencies.• Author or approve change controls, CAPAs, and Action Items for GMP instruments.Key Achievements• Over the course of a year, developed and executed a plan to manage the move of a GMP lab and GMP stability freezer farm to a new site through extensive cross-functional problem solving involving change controls, instrument and equipment re-qualifications, and coordination with third-party move managers and validation personnel.• Took the initiative to create and lead a team dedicated to uniting equipment and operational cultures of four separate GMP labs into one shared GMP lab and improve those operations over the last four years.• Led the Lab Data Workflow effort for the St. Louis Shared GMP lab, engaging with cross-functional planning, SOP authoring, training and implementation.• Outfitted two extension laboratories of the shared GMP lab space and implemented established laboratory culture in those areas.• Developed and performed multiple GMP related trainings for 100-200 people using Real Ware, PowerPoint, Excel and Teams.

St. Louis, Mo

• Subject Matter Expert for CGE, iCE and compendia methods, performing all manner of biochemistry testing related to these categories.• LIMS SME for the Quality Unit assisting scientists and ARD leads with remediation of issues experienced in LIMS/ELN.• QC testing lead for St. Louis Site overseeing the assignment of testing and ensuring its completion.• 5S Team Leader responsible for re-organizing the lab and applying 5S principles where applicable.• Compendia Technology Team Leader managing the periodic review of compendia related SOPs and addressing CAPA actions related to Compendia testing.• Equipment and instrumentation manager for QC lab overseeing approximately 100 instruments and pieces of GMP equipment.• Laboratory and Manufacturing investigation author, change management impact assessor and approver in QTS, writing 30+ investigations during this period.Key Achievements• Designed the Shared GMP lab for the new Bioplace facility.• >95% Right First Time on over 2000 samples tested

St Louis, Missouri, United States

• Perform release and stability testing for biologic drug substances and drug products.• Mentor and train new analysts on GMP principles and large molecule pharmaceutical technologies.• LIMS Super User and specification author

Ann Arbor, Michigan, United States

• Coordinator for the GMP excipient laboratory.• Trainer for USP and PhEur related analytical techniques.• Scientific reviewer of GMP instrument qualification documents.• Analytical chemist in the GMP excipient laboratory.

Rochester, Michigan, United States

• QC scientist responsible for training, leading investigations and performing equipment validation. • Team leader for the Equipment and Facilities team• QC analyst testing raw materials, API, drug products and stability samples in accordance with USP, Ph Eur and in-house procedures.