Brent Miller, M.S. Email & Phone Number

Madison, Wi, Us

Madison, Wisconsin, United States

Downstream Chromatography Subject Matter Expert, particularly in FPLC/column chromatography, manufacturing troubleshooting, and downstream process optimization. Lead the execution of downstream purification and mRNA production activities, including in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, bulk drug substance filling, and column packing/qualification. Provide advanced troubleshooting skills to ensure efficient resolution of issues, maintaining high-quality standards. Collaborate with operations leadership to develop and refine processes, ensuring contract obligations are met without delays. Design and execute process and equipment validation activities for purification processes. Adhere to cGMPs and GDPs ensuring RFT execution and accurate documentation of all activities. Identify deviations from standard procedures and raise awareness through the Rapid Response process, critically assessing operations for cGMP compliant troubleshooting. Lead Continuous Improvement (CI) activities, leveraging my expertise in industrial bioprocess to implement lean and agile manufacturing. Responsible for training for complex production activities. Mentor and coach junior team members, partnering with leadership to develop comprehensive training plans. Coordinate the implementation of SOP and batch record updates cross functionally in support of client demands. During Person In Plant (PIP) or virtual PIP observations, provide clients with detailed updates on batch schedules and statuses. Participate in daily shift musters and lead shift exchange activities among strategic targets.

Gaithersburg, Maryland, United States

Contribute to the design of experiments for the development and optimization of downstream biological production processes. Lead the execution of the experiments. Analyze data and author technical reports. Execute experimental protocols for developing/optimizing downstream manufacturing processes. Contribute to the development of scalable downstream processes to purify recombinant proteins, mAbs, and recombinant viruses. Assist in the technology transfer of developed processes to manufacturing sites. Trouble-shoot and maintain purification and tangential flow filtration systems. Prepare Operational and Maintenance Equipment SOPs and Development Batch Records. Author andreview of documentation such as Detailed Technical Plans, Technology Development Reports, and Technology Transfer Protocols. Knowledge of bioprocess unit operations specifically column chromatography, purification, depth filtration, and tangential flow filtration technologies. Extensive hands on experience using AKTA chromatography equipment (Avant 25/150, Pilot, Pure, Ready, Process), Tecan, and PendoTech TFF systems. Understanding of Design of Experiments and use of JMP statistical software.

United States

Operate various modes of column chromatography (ProA, AEX, CEX, HIC, etc.) purification procedures in a GMP compliant environment involved in the industrial manufacture of monoclonal antibodies belantamab mafodoxin and belimumab protein production in accordance with SOPs. Operate viral inactivation (low pH) assays, depth filtration, UFDF, TFF, SPTFF, bulk product formulation, and UV/Vis characterization. Knowledgeable on GMP compliance regulations and by-laws, Six-Sigma lean ways of work, process and assay design, and scale-up DoEs. Implemented batch record simplification project to streamline and develop robust compliant platforms for eBR instance rollout. Contributed to data analytics tool building through Power BI. Highly Proficient in SAP M-ERP, Delta-V, Syncade, UNICORN, LIMS, and Microsoft Power products. Purification SME with SOP author experience, Cross-functional leader across integrated and disintegrated value streams.

Rockville, Maryland, United States

Downstream-chromatography

Rockville, Maryland, United States

Performed various modes of Cytiva AKTA FPLC column chromatography in accordance with SOP and GLP documented processes. Observance to Part 11 compliant roles and execution of experimental bioanalytical procedures independently. Strong experience in troubleshooting and custom UNICORN method writing and programming. Client facing role in support of downstream manufacturing processes for various large proteins, monoclonal antibodies, vaccines, biologics/biosimilars, nucleic acids, and other biomolecules for purification and viral clearance testing. Regularly handled caustic reagents and live viral particulates.

Richmond, Virginia, United States

Vaccine Sciences Department- Biofunctional Assay GroupPerformed a variety of routine to complex sample preparations and analysis procedures toquantitatively measure pharmaceutical and biopharmaceutical compounds in a variety offormulations and/or biological matrices. Followed validated or experimental analytical procedureswith periodic direct supervision. Responsible for review and compilation of results and datacomparison against SOP acceptance criteria, methodology, protocol and product specifications. Routinely handled hazardous waste.• Executed Multiplexed Opsonophagocytic Assays (MOPA) to produce, develop, and validate vaccine candidates from Phase I-Phase IV• Performed routine and remedial maintenance on all lab equipment (pipettes, autoclave, incubators, etc.)

MS Microbiology and Cell Sciences, Concentration in Medical Microbiology and Biochemistry

Charles City, Va

• Performed nest checks and counts of wading birds in eastern Virginia• Maintained and set nutria (Myocastor coypus) traps along James River tributaries• Juvenile trophy bass stocking in Back Bay

* Handled point of sale transactions* Tested water chemistry and provided expert pool advice

Master Of Science - Ms Certificate Program, Drug Discovery And Development, 4.0

Master Of Science - Ms, Microbiology And Cell Science, Conc. Biochemistry

Bachelor Of Science (Bs), Biology/Biological Sciences, General