Summary
Overview
Work History
Education
Skills
Accomplishments
Student Undergraduate Researcher
Timeline
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Matt Fondersmith

Torrance

Summary

Technically skilled and detail-oriented product engineer with five years of hands-on experience in the pharmaceutical CMO industry. Proven ability to collaborate with cross-functional teams to develop and implement effective solutions to resolve production challenges, while ensuring compliance with regulatory standards.

Overview

4
4
years of professional experience

Work History

Product Engineer

Kindeva Drug Delivery
Northridge
09.2023 - Current
  • Collaborated with cross-functional teams including sales, marketing, manufacturing, and quality assurance.
  • Developed and implemented best practices, quality assurance standards and project management procedures.
  • Reviewed engineering drawings, process specifications, test requirements, inspection plans, and other technical documents for accuracy.
  • Developed reports summarizing key metrics related to product quality including defect rates, cycle time reduction efforts.
  • Reviewed customer feedback and complaints to identify quality issues and improvement opportunities.
  • Coordinated testing activities according to approved protocols and documented results accurately in a timely manner.
  • Led root cause analysis investigations for product nonconformances and process deficiencies. Implemented corrective and preventive actions in response to Investigative conclusions
  • Managed Supplier Corrective Action Reports (SCARs) to determine the root cause of raw material deficiencies in response to investigative conclusions.
  • Worked in fast-paced collaboration with all departments to design and deploy contingency plans to address manufacturing bottlenecks.

Production Chemist

Polypeptide Group Laboratories
Torrance
12.2020 - 09.2023
  • Lead projects/ processes required to manufacture active pharmaceutical ingredients (APIs) under FDA regulated GMP conditions.
  • Review and execute Installation and Operation Qualifications (IOQ), equipment Performance Qualifications (PQ), and process performance qualification (PPQ) on PMO manufacturing equipment.
  • Create and revise GMP compliant Master Batch Production Records (MBPRs) and Standard Operating Procedures (SOPs) per customer or quality system standards.
  • Facilitated successful tech transfer of a GMP manufacturing process directly from customer to large scale production, including creation of batch records, SOP's, and implementation of process controls.
  • Communicate with the customer’s QA and Technical teams to share information regarding continuous improvement projects, deviations, and CAPAs.

Education

Bachelor of Science - Chemistry

University of Missouri
Columbia, MO
05-2019

Skills

  • Root cause analysis
  • Continuous improvement
  • Process optimization
  • Technical documentation
  • Regulatory compliance awareness
  • Product lifecycle management

Accomplishments

  • Lean Six Sigma Green Belt
  • Continued education progress for Certified Quality Engineer (CQE) certification

Student Undergraduate Researcher

  • Worked in the health physics department at Missouri University Research Reactor (MURR), the largest nuclear research reactor on the continent.
  • Performed general upkeep duties and developed a passion for the nuclear industry and safe, sustainable practices therein.

Timeline

Product Engineer

Kindeva Drug Delivery
09.2023 - Current

Production Chemist

Polypeptide Group Laboratories
12.2020 - 09.2023

Bachelor of Science - Chemistry

University of Missouri

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Matt Fondersmith