Michael Brown

General Responsibilities

• Maintain housekeeping and safe working environment according to cGMP, comply with aseptic gowning, perform daily and weekly area sanitization including yearly shutdown and startup.
• Perform live documentation on all processes in BPR’s.
• Inspect to ensure all equipment and tanks including valves, hoses, rupture disks, pressure gauges and all hookups comply with SOP and BPR specifications.
• Pay close attention to equipment visually and listen out for any irregularities.
• Product and chemical inventory management using SAP program, monitor and order raw materials.
• Keep track of all materials used for each batch including chemicals, filters, buffers and test materials.
• Review all BPRs, documents and logbooks to ensure they meet quality standards.
• Maintained a safe work environment by strictly adhering to established safety protocols and guidelines.
• Performed troubleshooting and diagnosis on malfunctioning equipment.
• Demonstrated adaptability when faced with new challenges or technologies, enabling quick mastery of necessary skills.
• Conducted root cause analyses for recurring technical issues, minimizing future disruptions.

Upstream Processing

Zone 1 Albumin AFP (June 2024- Current)

• Retrieve, check weigh and document fraction V paste.
• Suspend fraction V paste in vessel of WFI and perform bag rinse for protein recovery.
• Monitor and manipulate the product’s pH, concentration, turbidity and temperature according to SOP and BPR.
• Preparation and initial clarification through CUNO zeta plus filters.
• Utilization of Ultra filters for concentration and dialysis/diafiltration.
• Preparation of numerous buffers including diafiltration salt buffers and caprylate/ tryptophan stabilizer.
• Critical viral inactivation heat shock for 3 hours.
• Transfer of product to zone 2 for further processing.
• Clean all filters, equipment skids and vessels according to BPR procedure, CIP cleanings or manual cleaning on vessels using pray ball recirculation method.

Downstream Processing

Zone 2 Alpha MP (December 2022-June 2024)

• Isolate the A1AT proteins using Anion and Cation Column Chromatography methods.
• Monitor and manipulate the product’s pH, concentration, conductivity and temperature according to SOP and BPR.
• Preparation of numerous buffers including column equilibration, wash and elution buffers, sanitation buffers and dilution buffers.
• Utilization of Ultra filters for concentration and diafiltration, hydrophilic and hydrophobic filters.
• Pretest and post-test filters using Integritest system or bubble point test.
• Critical viral removal nanofiltration with gold particle removal test
• Carefully inspect and weigh raw materials for excipient addition as stated per BPR.
• Perform final product formulation and bulk tank sterile filtration to be delivered to filling department.
• Clean all Columns, filters, equipment skids and vessels according to BPR procedure, CIP cleanings or manual cleaning of vessels.
• Perform asymmetry and HETP tests on chromatography columns.
• Prepare chromatography prefilters according to BPR and rinse with WFI.
• Build and sterilize bulk tanks in autoclave or BTS through steam sterilization.