Experience

Nucleus Biologics
• United States
• Biotechnology
• 1 - 100 Employee
• Technical Writer

  • Mar 2023 - Present


Fate Therapeutics Inc

• United States
• Biotechnology Research
• 200 - 300 Employee

• Senior Research Associate

  • May 2021 - Jan 2023

  - Produces human iPSCs using aseptic mammalian cell culture techniques specified in cGMP Manufacturing Batch Records and SOPs including, but not limited to media preparation, cell culture and scale up, cell counting, preparing cells for analysis, and cryopreservation. -Support manufacturing processes including material requesting, reagent aliquoting, equipment calibration, and area maintenance. -Execute and document Batch Records and SOPs with a high level of compliance with safety policies, quality system, and cGMP guidance. -Participates in writing or suggesting changes to controlled documents as needed to ensure defined quality objectives are met. - Contributes to iPSC group activities including protocol optimization, process automation, cell line derivation, and characterization of generated iPSC lines. -Contributes to experimental R&D design, execution, and data interpretation of projects. - Supports discovery pipeline and iPSC platform by adhering to, developing, and/or troubleshooting protocols for reprogramming and engineering of various cell types. - Genetic editing/engineering of various cell types, including using CRISPR engineering, and phenotypic and functional characterization related to the genetic modulation. - Collaborate and coordinate with various cross-functional teams to reach project objectives. -Participate in weekly group meetings and present updates pertaining to manufacturing activities, as well as, technical reports and data for R&D projects. Show less



ViaCyte

• United States
• Biotechnology Research
• 1 - 100 Employee

• Manfacturing Associate I

  • Jan 2019 - May 2021

  • Aseptically handled Embryonic Stem Cells master cell bank to expand inventory and working cell banks. • Aseptically handled Embryonic Stem Cells through the entire 2-week expansion from T-175 flasks to 10-Stack cell chambers. • Aseptically handled Embryonic Stem Cells daily during 2-week, large scale, roller bottle differentiation process. • Completed large scale media campaigns using a close system consisting of pumps, manifolds, and large volume bagged media. • Aseptically performed scheduled thaws and harvests of aggregates for a 3-day Downstream process for direct implantation into clinical trial patients. • Aseptically performed manual cryopreservation process, using a Capper/Decapper and the automated Sartorius Fill-it System. • Provide hands on support for scale out/up and development activities as needed based on a demand plan., which included the implementation of the Fill-It system for cryopreservation. • Generate and revise applicable GMP documentation including batch records, SOP’s, deviations, change requests, CAPA’s, IOQ’s, technical reports, and other documents. • Maintain GMP areas in a constant state of inspection readiness related to equipment and area preventive maintenance, calibration, and certification. • Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions and comply with regulatory requirements. Show less



PaxVax, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate QC chemist

  • Oct 2017 - Jan 2019

  • Perform in-process and release testing of bulk drug substance, lyophilized powder, and drug product. • Perform raw material testing on various solutions and media products for release. • Performs all required QC tests such as Moisture Content, Viable Cell Count, Appearance, Visual Control, and Package Integrity. • Performs testing for other QC systems such as the Environmental Monitoring program and Microbiology testing. • Compiles and reviews data for documentation of test procedures and prepares reports. • Perform investigations for out of specification or limits occurrences and deviations. • Performed method validation for Growth promotion, Bioburden, and Microbial Identification. Show less



PCI Pharma Services

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Chemist

  • Apr 2016 - May 2017

  • Performed stability and In-process testing methods such as; Potency, Related compounds/Impurity assays using HPLC/UHPLC on a daily basis. • Demonstrated GLP and GDP on a daily basis to ensure testing was performed correctly the first time, as well as to maintain a quality lab notebook. • Perform, troubleshoot, and investigate work related to OOS and Out of Tread occurrences. • Routine maintenance, calibration, and troubleshooting for Analytical equipment including IQ/OQ/PQ of laboratory equipment. • Performed customer method transfers and method validations for Assay testing. • Developed a daily performance checklist for new employees to use after training was completed. Show less


EPS-Materials
• United Kingdom
• Wholesale
• 1 - 100 Employee
• Lab Technician

  • Oct 2015 - Apr 2016