Hillary Hillmann Email & Phone Number

Raleigh, Nc, Us

Memphis, Tennessee, United States

• Oversees a Quality Control team of 75 direct/indirect reports, including environmental monitoring, microbiology testing, analytical and bioassay testing, stability, sample control, outsource testing, and raw material testing groups at Charles River's Cell Therapy Biologics CDMO• Serves as a member of the Site Leadership Team and drives accountability and continuous improvement• Represents Quality Control in regulatory and client audits, as well as client facing meetings• Tracks and develops KPIs to assess team performance, capacity, and turnaround times• Collaborates cross-functionally to create tools to improve site performance, such as implementing structured tier meetings to track deliverables, escalations, and other site milestones• Manages CapEx and OpEx budgets to maintain quality, capacity, and efficiency• Supports manufacturing production and disposition for early/late phase and commercial clients

Alachua, Florida, United States

• Oversaw GMP Viral Vector Services (Gene Therapy CDMO) Quality Control team of 40 people at including but not limited to molecular, cell-based, analytical and microbial testing, environmental qualification and environmental monitoring, outsource testing, method transfer, qualification and validation of assays, stability programs, lab services, and release of product• Established specifications and sampling plans to support Clinical Drug Substance, Drug Product, Viral Bank, and Cell Bank Manufacturing; authors certificates of analysis and certificates of testing to support product release• Managed the CapEx and OpEx budgets to enhance efficiency and maintain quality/compliance at high levels• Developed, directed, and maintained quality systems in the laboratory in support of manufacturing consistent with global quality systems requirements, corporate standards, and current regulatory requirements• QC subject matter expert for regulatory inspections and client audits; attends client facing meetings• Applied expert Quality Control experience to ensure operations meet customer and regulatory expectations and requirements at all phases of product development• Established department / individual goals and KPIs in alignment with company and operational goals; maintained and reported department and delivery metrics• Drove continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems by instilling strong ownership and accountability

Alachua, Florida, United States

• Managed a team of Scientists and Specialists within Quality Control• Supported establishment and/or enhancement of QC and operational metrics• Subject matter expert responsible for ensuring GMP reports, including Deviations, OOS investigations, CAPAs and Change controls are properly investigated, implemented, executed and/or remain effective• Drafted and reviewed release specifications, certificates of testing, certificates of analysis and sampling plans for client programs (Drug Substance, Drug Product, Viral Banks, and Cell Banks)• Supported the assay qualification/validation and stability teams by authoring and reviewing Assay Qualification Protocols, Summary Reports, and Stability Protocols.• Scheduled all QC testing to support client programs and their GMP release, assay qualification, and stability testing

• Prepared and maintained schedules for testing of in-process and final product, assay qualifications, and stability testing• Represented QC as the subject matter expert in client facing meetings and audits• Ensured timely review and reporting of release testing and stability timepoints; generates reports and CoAs as needed• Prepared release specifications and sampling plans for GMP batch records• Managed all laboratory exceptions, including OOS, deviations, change controls, and CAPAs• Supervised and trained staff on the performance of assays, document preparation, and execution

Alachua, Fl

• Created, revised, and edited QC SOPs, test records, reagent preparation records, stability protocols, and assay qualification protocols and reports• Tracked initiation and progress of all QC quality exceptions and provided monthly metrics to management• Wrote out of specification and deviation investigations, CAPAs, Change Controls, and Planned Variances and served as the QC representative and subject matter expert for internal and external client meetings• Reviewed executed test records and documented review in LIMS as required

Alachua, Florida, United States

• Developed, qualified, and conducted cell, nucleic acid, protein, and chemistry-based assays in a GMP laboratory• Functioned as the subject matter expert on QC assays and responsible for supervising two scientists • Project lead in QC for two incoming clients/projects, which included overseeing planning and coordinating

Raleigh-Durham, North Carolina Area

• Supervised testing personnel and provided technical support for high complexity testing• Created, reviewed, revised, and updated laboratory SOPs • Performed DNA/RNA extractions and RT-PCR on Hepatitis B and HIV samples using the Abbott m2000 and NucliSens easyMAG systems

Raleigh-Durham, North Carolina Area

• Performed qualitative and quantitative analysis of nucleic acids by using Nanodrop, Quibit, Picogreen, Agilent Bioanalyzer, and Lonza FlashGel; performed DNA and RNA isolations using a variety of isolation techniques• Identified process improvements to increase data quality, lower costs, and reduce turnaround times

Raleigh, North Carolina

• Performed cell culture, DNA/RNA extraction, PCR, western blotting, and immunofluorescence assays on extracted tissues, utilizing flow cytometry• Supervised three graduate students and maintained the upkeep of the mouse colony and all in house cell lines

Alachua, Florida

• Performed fluorescence-activated cell sorting (FACS) analysis, ViCell viability, cell culture assays, SDS-PAGE, western blot, ELIAS-based assays, and qPCR in accordance with SOPs• Wrote test records, SOPs, reagent preparation records, and raw material specifications as assigned

Gainesville, Florida

• Responsible for research focused on designing and screening experimental insecticides • Performed enzymatic assays and topical bioassays to determine insecticide inhibition and selectivity

Master Of Science (M.S.), Entomology, Biochemistry

Bachelor Of Science (B.S.), Biology, Chemistry

Activities and Societies: American Chemical Society