Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Spencer Richards

San Diego,CA

Summary

To contribute to a fast-paced discovery team working to produce/develop next generation diagnostics / therapies to improve human health. Meticulous and well-trained laboratory team member bringing top-notch expertise in analyzing materials and contributing to successful product development. Solid background boosting quality of production with systematic review and on-going support. Demonstrated knowledge of experimental and practical application strategies.

Overview

10
10
years of professional experience

Work History

Senior MFG Associate/Formulator

Agena Biosciences
08.2020 - 01.2024
  • 4 years' experience in staging raw materials for PCR Reagent Kits and Bulk Formulation Mixes
  • Daily meetings with MFG Lead/Senior Scientists on Assay Formulation/Production schedule
  • Lead GMP formulation of complex mixes for integration into diagnostic assay systems
  • Make dilutions and run samples on MA4 Mass Spectrometry Instrumentation
  • Make detailed observations, analyze data, interpret results, and maintain records
  • Collaborate with team members in the Applications, R&D and Manufacturing, Materials, Regulatory and Quality departments
  • Assisted R&D in validation and transfer of new Assay Panels
  • Assisted in spotting of Matrix onto Microarray MALDI Chips creating 96/384 data points
  • Train manufacture associates in assembly of PCR Reagent Kits
  • Molecular biology consumables
  • Create Change Orders to implement new WKI's, SOP's and MBR's
  • Helped QC with the calibration and validation of laboratory equipment
  • Label, fill and prep various reagent kits utilizing raw materials
  • Complies with documentation and production record keeping
  • Monthly cycle counts which supported the restructuring of materials needed.

Manufacture Associate II

Poseida Therapeutics
09.2019 - 03.2020
  • Manufactured DNA/RNA for CAR T-Cell Therapy
  • Processes were performed with the highest integrity which reinforced the company's philosophy
  • Performed Ecoli Transformation using pDNA and ecoli cells via heat shock
  • Proficient at inoculation of LB Broth with ecoli cells for culture expansion
  • Performed Optical Density testing on Nanodrop OD 600
  • Experienced in isolation, purification and scale up of plasmid DNA using Qiagen PCR Purification Giga Free Kit for CART T Cell Therapy
  • Performed DNA Electrophoresis to observe DNA band size on Chem IT Imaging System for spectrum analysis
  • Performed manufacturing of mRNA via IVT and Poly A Tail reaction
  • Use of Qiagen T7mMessage / mRNA Purification Kits
  • Kept daily record of procedure(s) and results
  • Assisted other departments when needed.

Manufacture Associate

Trilink Technologies
03.2019 - 09.2019
  • Trained in setup, operate and tear down of Gilson 280-X HPLC system for Anion Exchange Chromatography for purification of Oligonucleotide products
  • Experience in isolating oligo products on a RotoVap system in an ISO 13485 and ISO 9001 cGMP environment
  • Experienced in selection of mock pool fractions, pooling of fractions and RotoVap of Oligonucleotide products
  • Proficient in Optical Density testing of purified oligonucleotide products
  • Daily submitting of QC samples using an HPLC Vanquish system.

QC Technician I

Accriva Diagnostic's
06.2018 - 01.2019
  • Performed IVD Diagnostic testing in an ISO 13485 and ISO 9001 cGMP environment
  • Completed Blood/Pathogen Training Program for QC/IVD Diagnostic equipment
  • Experienced in QCBD Software System and OOS documentation report write ups
  • Performed daily QC testing of Hemochron Signature Elite, Response, Signature +, IDEXX Coag DX and VerifyNow instruments using donor blood and B carbon filler devices
  • Experienced in SOP Revision and MBR Revision.

Laboratory Technician

Genway Incorporated
05.2017 - 04.2018
  • Proficient in calibrating pH and temperature probes for setup of 20L bioreactors
  • Experienced in buffer preparation for recombinant protein research
  • Experienced in preparation and inoculation of selective media with yeast/bacteria cells for recombinant protein research
  • Experienced in OD600 testing of yeast cells for cell growth
  • Two years' experience in harvesting and cryopreserving yeast/bacteria cells
  • Proficient in cleaning and resin packing of 1L purification columns for protein purification
  • Assisted QA Manager in scheduling Biohazard waste pickup
  • Scheduled calibration appointments for over 100 pieces of lab equipment.

Production Operator I

Pacira Pharmaceuticals
01.2014 - 03.2017
  • ISO 100, cGMP 13485 and ISO 9001 qualified
  • Class 100 clean room gown qualified in production of Exparel product
  • Experience in operating/troubleshooting pneumatic fill/finish machinery
  • Exparel inspection qualified
  • SOP/PBR revision qualified
  • Monitored inventory and completed monthly cycle counts
  • Trained in fill room component preparation and integrity filter testing.

Education

Skills

  • 4 years' experience in Wet Chemistry for complex diagnostic oligonucleotide mixes, MasterMixes
  • 1 year experience in DNA/RNA mfg, isolation and purification
  • 5 years' experience in measuring, pipetting/dispensing of final product
  • Proficient in Batch Record review, ultimately yielding in NetSuite (component in ERP)
  • Well established in Batch Record review to hand off to QA in timely manner
  • Proactive in mfg lab safety and cleanliness
  • 5 years' experience in collecting, packaging and disposing of biohazard material
  • Experienced in completing raw material cycle counts and addressing any discrepancies
  • Efficient in identifying/troubleshooting problem areas
  • Able to maintain quality production during FDA Audits
  • Proactive in identifying/correcting problem areas to maintain well-ordered/disciplined production schedule
  • Microsoft Office 2010
  • Microsoft Office Excel
  • JumpGene
  • Typer V

References

  • Michael Mosko, Research Scientist III, Agena Biosciences, Michael.Mosko@agenabio.com
  • Sean Chang, Product Development Scientist, 979-422-7038, seanchang1984@gmail.com
  • Peter Duarte, Supervisor, BioQC, Accriva Diagnostics, 619-972-8818
  • Matt Landry, Vice President of Marketing and Sales, Genway Inc, 858-945-6281
  • Kent Chamness, Production Supervisor, Pacira Pharmaceuticals, 1-619-655-9603

Timeline

Senior MFG Associate/Formulator

Agena Biosciences
08.2020 - 01.2024

Manufacture Associate II

Poseida Therapeutics
09.2019 - 03.2020

Manufacture Associate

Trilink Technologies
03.2019 - 09.2019

QC Technician I

Accriva Diagnostic's
06.2018 - 01.2019

Laboratory Technician

Genway Incorporated
05.2017 - 04.2018

Production Operator I

Pacira Pharmaceuticals
01.2014 - 03.2017

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Spencer Richards