Steven Derby Email & Phone Number

East Bridgewater, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

• Setup GMP environment to improve the manufacturing processes for drug substance and product• Ensure manufacturing compliance to cGMPs standards by authoring and revising SOPs/batch records and quality docs• Operate and maintain small-scale process equipment in compliance with production batch records, SOPs, and cGMP• Mine data from batch records, equipment logs, and other documents to create graphs for technology transfer documents and the IND report• Ensure optimal operation by managing 3rd party contractors for preventative maintenance and calibrations• Implement best practices while operating lyophilizer and sanitizing it with VHP• Supervise large-scale buffer, media preparation, and single-use components for GMP manufacturing operations• Lead continuous improvement projects in inventory control, BSC cleanings, and bacterial mitigation and walkthroughs

Cambridge, Massachusetts, Us

• Performed purification activities such as column packing, chromatography, viral filtration, UF/DF, and method editing• Spearheaded troubleshooting, investigation, and root cause analysis of process problems in cGMP environment• Overall responsibility for cell culture expansion steps, bioreactor operations, clarification, depth filtration, and media preparation• Utilized strong leadership and mentoring skills to coach and train associates to deliver production objectives• Increased line efficiencies and streamlined operations by strategizing with management on personnel, schedules and timelines, new equipment, and other on-the-floor needs and events• Facilitated suite shutdown, changeover, and cleaning protocols to maintain a safe working environment• Provided senior level technical oversight to the production and drug loading of Nano Liposomal encapsulations

Cambridge, Massachusetts, Us

• Performed cell culture tasks e.g. cell culture expansion steps, bioreactor operations, clarification, depth filtration, and media preparation• Accomplished purification activities such as column packing/unpacking, column chromatography, viral filtration, and ultrafiltration / diafiltration• Collaborated with cross-functional teams (QA, QC, Materials, Maintenance) to ensure timely delivery of deadlines and with outside contractors for equipment calibration and preventative maintenance• Downstream Equipment Manager: Maintained, operated and troubleshot all laboratory equipment such as but not limited to autoclaves, incubators, scales, bio-safety cabinets, skids, gauges, and meters

Thousand Oaks, Ca, Us

• Managed CIP, SIP, and operation of bioreactors, filter trains, and TFF skids for the production of Enbrel from the mammalian CHO cell• Executed nutrient additions for reactors and supported troubleshooting operations• Evaluated sample variables to ensure results are within ranges• Collaborated with other departments such as process services, purification, and maintenance to ensure compliance with company’s corporate quality governance, and GMP safety and schedules

• Plasma Spray Experience, Machining• QA/QC Experience, Research & Development

Bs; Science, Biology; General Biology, General Chemistry, Organic Chemistry, Biochemistry, Physics

High School