Summary
Overview
Work History
Education
Skills
Timeline
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Erik Klemp

Sarasota,FL

Summary

Enthusiastic biotechnologist eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of cGMP and training in bioprocess manufacturing. Motivated to learn, grow and excel in biotechnology.

Overview

6
6
years of professional experience

Work History

Lead Manufacturing Associate

Akron Biotechnology
09.2021 - Current
  • Lead Upstream CGMP activities by authoring, reviewing and approving Master and Production Batch Records , Standard Operating Procedures (SOPs), Process Flow Diagrams (PFDs), Work Instructions (WIs) and Bill of Materials (BoMs).
  • Acted as Upstream Subject Matter Expert (SME) by troubleshooting process and equipment issues, drafting component and raw material specifications, leading and overseeing production activities and collaborated with process development department and MSAT to ensure successful tech transfer of robust manufacturing processes.
  • Lead Downstream (TFF) CGMP activities by authoring, reviewing and approving Master and Production Batch Records , Standard Operating Procedures (SOPs), Process Flow Diagrams (PFDs), Work Instructions (WIs) and Bill of Materials (BoMs).
  • Supported Quality for drafting and reviewing Investigations, CAPAs, Root Cause Analysis (RCA) and Deviation.
  • Collect, organize, and analyze process data from engineering and manufacturing runs for presentation.

Scientist 1, Upstream Manufacturing

Thermo Fisher Scientific Inc.
11.2020 - 08.2021
  • Supported Upstream cGMP manufacturing activities to ensure that Thermo Fisher provides clients with investigational materials for pre-clinical and clinical use. cGMP production of Master Cell Banks (MCB), Master Viral Banks (MVB), recombinant protein and viral vectors under supervision of the Upstream Manufacturing Supervisor/Manager. Reviewed executed records related to production activities, write or review deviations, investigations, etc. related to cGMP production. Was expected to prepare and modify documents (SOPs, PBRs, RMSs, qualification protocols, etc) required for cGMP production, and to maintain equipment in the upstream production suites. Worked closely with Production Development, Facilities, Quality Assurance, and Quality Control units to achieve production goals and timelines.

Laboratory Manager/Research Assistant

University of Florida, College of Vet. Medicine
03.2019 - 10.2020
  • Performed veterinary viral and immunological assays such as Western and Immunoblot, hematological differentials and analysis, data analysis, cell culture, cell banking and assist in restraining animals for blood collection.

Education

Master of Science - Biomanufacturing

North Carolina State University
Raleigh, NC
05-2027

Bachelor of Science - Biology

University of Florida
Gainesville, FL
05-2018

Skills

  • Cell Culture
  • Bioreactors
  • Wave Reactors
  • Fermentation
  • Fermentors
  • Aseptic Technique
  • Sterile Gowning
  • Tangential Flow Filtration
  • Centrifugation
  • Clarification
  • Cell Banking
  • Single Use Technologies
  • Root Cause Analysis
  • MS Excel
  • Good Documentation Practices
  • Troubleshooting
  • Technical Writing
  • Mentoring
  • Communication
  • Training

Timeline

Lead Manufacturing Associate

Akron Biotechnology
09.2021 - Current

Scientist 1, Upstream Manufacturing

Thermo Fisher Scientific Inc.
11.2020 - 08.2021

Laboratory Manager/Research Assistant

University of Florida, College of Vet. Medicine
03.2019 - 10.2020

Master of Science - Biomanufacturing

North Carolina State University

Bachelor of Science - Biology

University of Florida

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Erik Klemp