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, MO05-2019
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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