Summary
Overview
Work History
Education
Skills
Timeline
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Miles Malefyt

Manufacturing Associate
Millbrae,CA

Summary

Proven Manufacturing Associate with a track record of enhancing operational efficiency at Astellas Gene Therapies. Specializes in aseptic technique and process implementation, demonstrating exceptional skill in procedural manual drafting and instruction development. Excelled in QC and manufacturing roles, significantly contributing to compliance and production excellence. Combines analytical prowess with strong training capabilities, ensuring adherence to cGMP standards.

Overview

8
8
years of professional experience
5
5
years of post-secondary education

Work History

Senior Manufacturing Associate

Metagenomi
04.2023 - Current
  • Generate GMP Batch Records and SOPs for Processes and Buffers from given process description from process development department to make GMP material while collaborating with QA to meet compliance.
  • Performed both upstream with e.coli for protein production utilizing Shake Flask, 30L Bioreactor, homogenizer, centrifuge, and depth filtration.
  • Nanodrop and Solo VPE testing
  • Downstream ops with AKTA Pilot 600R using AEX, CEX, and IMAC chromatography.
  • Aseptic Filling Ops .
  • Supported cross-functional teams in troubleshooting complex manufacturing issues.
  • Initiated Deviations, CAPA, and Change Controls, and drove process through to close out.
  • Worked with maintenance to set calibration work needed and scheduling on GMP equipment
  • Worked with vendors to qualify GMP equipment using System Impact assessments, User Requirement Specifications, IQ, and OQ activities while following Validation Master Plan.
  • Worked with Facilities to implement ECCMS system
  • Worked with QC department to generate SPECS for suitable cGMP material
  • Led cross functional meetings to drive mRNA production implementation

Manufacturing Associate

Astellas Gene Therapies
8 2021 - 04.2023
  • AAV Production in Seed Train to Harvest
  • Supported Severe Adverse Event Investigation
  • 60L and 500L Bioreactor operation
  • Revised SOPs to drive continuous improvement
  • Buffer preparation for upstream and downstream operations
  • Exposure to TFF and Column Chromatography Operations
  • Qualified in Column testing, Sanitization and storage, Component testing, and Flow Kit Installation

Manufacturing Technician

Gilead
01.2019 - 08.2021
  • Formulated intermediate product from raw ingredients while complying with SOPs, E-procedures, and MPRs
  • Performing Intermediate reductions on intermediate product
  • Set up and breakdown of Tanks as well as parts and machinery for Production,CIP, SIP, and manual cleaning
  • Dispensed raw materials for production following MPRs and SOPs
  • Knowledgeable in Oracle EBS
  • Experienced in ISO 8 classed cleanroom gowning

QC Microbiologist

Gilead
10.2016 - 01.2019
  • Performing validation and qualification activities to bring La Verne project site up and into compliance.
  • Sampled and tested gasses, water, and clean rooms to validate and qualify for pharmaceutical production.
  • APA qualified and knowledgeable in aseptic technique.
  • Familiar with use of LIMS.
  • Wrote SOPs for EM program for new site as well as JHAs. Qualified as trainer.
  • Became very familiar with cGMP compliance as well as GDP.

Education

Bachelor of Science - Biology

Loyola Marymount University
Los Angeles, CA
08.2009 - 05.2014

Skills

Processes Implementation

Timeline

Senior Manufacturing Associate

Metagenomi
04.2023 - Current

Manufacturing Technician

Gilead
01.2019 - 08.2021

QC Microbiologist

Gilead
10.2016 - 01.2019

Bachelor of Science - Biology

Loyola Marymount University
08.2009 - 05.2014

Manufacturing Associate

Astellas Gene Therapies
8 2021 - 04.2023

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Miles MalefytManufacturing Associate