Experience

Geltor

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Process Development Associate

  • Jun 2021 - Present

  • Operating protein extraction, TFF, column adsorption and other protein processing technologies and equipment. • Draft, review and update equipment process and cleaning SOPs. • Participate in process troubleshooting related to process, product quality and equipment. • Support successful technology transfer and scale-up of processes to CRO/CMO partners. • Implemented logbook tracking system to meet cGMP requirement. • Operating protein extraction, TFF, column adsorption and other protein processing technologies and equipment. • Draft, review and update equipment process and cleaning SOPs. • Participate in process troubleshooting related to process, product quality and equipment. • Support successful technology transfer and scale-up of processes to CRO/CMO partners. • Implemented logbook tracking system to meet cGMP requirement.



BioMarin Pharmaceutical Inc.

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Manufacturing Associate- Downstream

  • Jun 2019 - Present

  • Proficient in Purification operations specifically in chromatography column operations, UF-DF, TFF depth filtration, and centrifugation.• Prepare media for upstream operations and prepare buffers for downstream operations.• Assist leads with setting daily priorities and production scheduling for the week.• Serve as Subject Matter Expert and primary trainer for all manufacturing support group operations. Also train new hires on downstream operations and make sure they are in full compliance in adherence to cGMP regulations and guidelines across clinical and commercial drug campaigns.• Timely review controlled documents such as batch records and equipment logbooks.• Assist in minor changes on Standard Operating Procedures and assist in completing Corrective and Preventative Actions.• Initiate process deviations and gathering initial details relevant to the event.

• Manufacturing Associate- Process Service

  • Jul 2016 - Jun 2019

  • Subject Matter Expert (SME) for all large and small scale of media and buffer solutions for Cell Culture and Purification operations in 3 different commercial manufacturing facilities.• Strictly followed Good Manufacturing Practice (GMP) and Standard Operating Procedures (SOP) for operations for cleaning and steaming equipment used for solution prep.• Assist Specialist and Engineering group with validation runs.• Operate glasswash and autoclave for sterilization of equipments.• Train new hires (cohorts ranging from 5-15 people) on cleanroom gowning and material flow, and basic GxP procedures• Assist in dry-run testing electronic batch records in Oracle MES.



Famous Medical Instrument

• Intern

  • Jun 2012 - Jun 2015

  •Efficiently manage files •Data entry •Receptionist •Create catalogs and quotes for clients •Design and maintain website •Respond to international clients via phone and email •Generate shipping quotes for import and export •Efficiently manage files •Data entry •Receptionist •Create catalogs and quotes for clients •Design and maintain website •Respond to international clients via phone and email •Generate shipping quotes for import and export