Senior Project Manager @ From December 2015 to Present (1 month) Sr. Group Leader @ •All duties listed in prior position (Group Leader) •Directly manages a team of individual contributors and people managers for Meningococcal Serum Bactericidal Assays (Mn SBA), Varicella-Zoster virus (VZV) and Human Papillomavirus (HPV) PCR and Multiplexed HPV Luminex Immunoassay programs supporting vaccine and biologic development, from preclinical to post-approval (Phase I-IV testing). •Trained new analysts on client procedures (including clinical data review and upload into LIMS) and also ensured all active users are up to date in all client-related systems. •Scheduled daily activities for ~40 laboratory staff that supported and/or performed clinical testing for Mn SBA using baby rabbit complement. •Responded to client’s questions and assisted in troubleshooting assay issues during pre-Technology Transfer validation, Technology Transfer validation, clinical testing, and post testing confirmation experiments. Provided recommendations on assay and compliance issues. •Leads/supports assay and method transfer efforts for various assays and assists in the development of a new LIMS module for those functional assays at the Richmond, VA facility. •Created a detailed process flow from sample in to data out for an ELISA assay that is being used to identify gaps and implement process improvements at the Richmond, VA facility. •Created a detailed process flow the new Anatomical Pathology lab to help identify gaps and implement a new process using the current LIMS system and to evaluate/create a process for the use of a new diagnostic pathology support system. Serves as Project Manager for the overall Anatomical Pathology project at the Highland Heights, KY facility. •Serves as Project Manager for Building Renovation/Construction and Laboratory Relocation project at the Highland Heights, KY facility. From April 2013 to November 2015 (2 years 8 months) Group Leader @ •Directly managed a team of individual contributors and people managers for Meningococcal Serum Bactericidal Assay (Mn SBA) program supporting vaccine and biologic development, from preclinical to post-approval (Phase I-IV testing). •Served as the SME for Mn SBA assays using human complement and Thermo Matrix’s Plate Mate Plus (PMP) liquid handling system and client data system such as reagent/material database, SAS, and LIMS. •Trained new analysts on client specific assays and procedures and also ensured all trainings are up to date for all client-related systems and processes. •Scheduled daily activities for ~ 20 laboratory staff that supported and/or performed clinical testing and assay development for Mn SBA using human complement including Hamilton liquid handling system staff and data reviewers. Also scheduled equipment and lab maintenance based on laboratory testing schedule. •Reviewed and approved study protocols, project status reports, final study reports and other project related technical documents. Helped client design experimental studies and participated in technical troubleshooting. •Approved laboratory investigations, deviations, QA facility and data audits. •Provided resources for project activities and needs, oversaw daily operations to monitor quality and project timeliness, and assist in preparation and implementation of company policies, quality systems and training programs. •Reviewed timesheet reports for billing accuracy. •Followed GCLP. From October 2011 to April 2013 (1 year 7 months) Manager, Manufacturing Services @ •Directly managed a team of individual contributors and people managers. •Managed daily virus manufacturing, cell culture (related to biologics testing) and mammalian/insect cell bank laboratory activities and scheduling. •Prepared monthly/weekly manufacturing and related testing schedules. •Oversaw raw material and cell bank inventory. •Assisted in the preparation and maintenance of cultured cells in the labs when needed (~35 different internal and client cell lines). •Identified manufacturing and related testing issues and proposes solutions. •Performed investigations and root cause analysis. •Remained in contact with clients in the US and internationally to assist with questions or troubleshooting issues from initiation of cell bank production/lot release testing through final release of cell bank or data. •Maintained and revised documentation related to the manufacture of vaccine, cell culture and cell banks including batch records, SOPs, and Final Cell Banking production reports. •Reviewed batch records and all ancillary documentation. •Developed and maintained departmental systems and SOPs. •Ensured technicians/operators were qualified and trained and trained technical personnel in laboratory skills. •Ensured compliance with regulatory concepts (cGMP, EMEA, OSHA) and specific laboratory techniques. From March 2010 to October 2011 (1 year 8 months) Cell Banking/Cell Therapy Supervisor @ •All duties listed in prior position (Senior Associate) •Performed all scheduling of cell banks and personnel. •Routinely met with clients (US and internationally based) during audits, visits and conference calls. •Performed banking of cell therapeutics utilizing 10-layer/40 layer cell stack flasks and filter trains and bags. •Authored, revised, and reviewed Cell Bank summary reports. •Reviewed batch records and all ancillary documentation. •Created custom cell line verification run plans/worksheets for each client as needed and performed cell line verification runs as necessary. •Was responsible for maintenance, record keeping and monitoring of equipment. •Participated in implementing Lean Sigma through training and data collection. From February 2008 to March 2010 (2 years 2 months) Cell Banking Senior Associate @ •Performed contract manufacturing of master / working adherent and suspension cell banks and small-scale GMP upstream production runs utilizing roller bottles, tissue culture, shaker, and spinner flasks. •Trained new personnel on cell banking procedures. •Authored, revised, and reviewed SOPs and batch custom records. •Followed assigned projects from beginning to end and worked with other departments to ensure all materials were available for the projects. •Performed Process Development activities as necessary. •Was responsible for maintenance, record keeping and monitoring of equipment. •Assumed the leadership role when area management was not available. •Followed cGMP. From May 2006 to February 2008 (1 year 10 months) Mycoplasma Testing Laboratory Supervisor @ •Managed all aspects of Research, Points to Consider, European, compendial and custom mycoplasma testing. Prepared tissue culture cells used for testing. •Performed validations and qualifications of custom assays as well as regular contract testing when needed. •Worked directly with clients ensuring all testing is done in a timely and efficient manner. •Reviewed batch records, technical data sheets, equipment records/charts and environmental sampling. •Authored and revised SOPs and batch records. •Prepared all mycoplasma media, stocks and characterization. •Cleaned and monitored equipment. •Followed cGMP, cGLP, and ISO. From August 2004 to April 2006 (1 year 9 months) Reseach Associate I (Cell Biology/Mycoplasma Testing Laboratories) @ •Managed all aspects of Research, Points to Consider, European, compendial and custom mycoplasma testing. Prepared tissue culture cells used for testing. •Performed validations and qualifications of custom assays as well as regular contract testing when needed. •Worked directly with clients ensuring all testing is done in a timely and efficient manner. •Reviewed batch records, technical data sheets, equipment records/charts and environmental sampling. •Authored and revised SOPs and batch records. •Prepared all mycoplasma media, stocks and characterization. •Cleaned and monitored equipment. •Followed cGMP, cGLP, and ISO. From August 2003 to August 2004 (1 year 1 month) QC Shift Clerk @ •Logged samples into a sample tracking database and keeping it up to date. •Organized, filled out, and occasionally filed sample flow logs. •Maintained sample bins by organizing by product number and destroyed samples (controlled and non-controlled) as they were released. •Documented samples processed in the lab at the end of the shift using Excel spreadsheet. •Served as a liaison between production workers and QC Chemists. •Trained in most wet chemistry techniques. •Followed cGMP. From November 2002 to August 2003 (10 months) Lab Assistant - Carcinogenesis Lab @ •Prepared solutions for use by researchers. •Served as support in various clean-up jobs and maintenance of equipment. •Performed various office responsibilities such as operating phones and fax, copying, greeting visitors, stocking and ordering of supplies and up keep of Access databases. •Oversaw other students and assigned tasks on a weekly basis. •Completed a research project involving actin's role in forming a cytoskeleton within cells. From February 1999 to May 2002 (3 years 4 months) Lab Assistant - Microbiology @ •Prepared solutions for use by students in laboratory classes and sterilization of equipment and solutions. From July 1999 to December 1999 (6 months)

Bachelor’s Degree, Human Biology @ Michigan State University From 1997 to 2002 Sheryl Brown-Lewis is skilled in: Life Sciences, GMP, GLP, SOP, Cell, Laboratory, Biopharmaceuticals, Pharmaceutical Industry, Technology Transfer, CAPA, LIMS, Biotechnology, Lifesciences, Quality Control, Cell Culture, Sop, Microbiology