Benjamin Mittman
Associate III, Quality Control at Biogen
- Role
- Associate Iii, Quality Control at Biogen
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
Experience
Associate Iii, Quality Control
Sep 2017 — Present · Morrisville, NC, US
Responsible for contributing to key functional, tactical, strategic and operational aspects of large molecule testing for Biochemistry group.• Responsibilities include, but are not limited to, project management, in-process release testing, acting as a liaison for method transfer validation testing and related activities associated with testing. • Review test data and documentation in a timely manner to ensure accuracy, completeness, and compliance with GMP regulations and SOPs. • Supports QC Biochemistry operations related to business and manufacturing schedules; • Support analytical method transfer, qualification, validation, and continuous improvement initiatives;• Collaborate with internal and external partners on method transfers and analytical improvement projects; • Support maintenance of laboratory systems to ensure data integrity and regulatory compliance.• Supports investigations impacting the QC department; Identifies and assists with implementation of corrective actions and root cause analysis• Ensures compliance to all GLP/GMP requirements, interfacing with Quality, MS, AT, and manufacturing as applicable;• Works on process improvements, actively supports management and QC teams;• Identifies and troubleshoots technical/operational problems, and works with management to understand and implement solutions;• Responsible for the execution of analytical methods including, but not limited to, HPLC, UPLC, CE, SDS, PAGE, pH, PC, and Appearance;
Education
The University of North Carolina at Chapel Hill
Graduate Certificate, Cytotechnology
North Carolina Agricultural and Technical State University
Bachelor of Science, Biology
Skills
- Pathology
- Radiopharmaceuticals
- Analytical Chemistry
- Good Laboratory Practice (Glp)
- Clinical Laboratory Improvement Amendments (Clia)
- Management
- Chemstation
- Laboratory
- Microscopy
- Quality Assurance
- Validation
- Mass Spectrometry
- Science
- Laboratory Skills
- Radiation Safety
- Gc-Ms
- Biotechnology
- Chromatography
- Public Speaking
- Cell Biology
- Sop
- Lc-Ms
- Life Sciences
- Troubleshooting
- Laboratory Medicine
- Research
- Data Analysis
- Chemistry
- Lifesciences
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Gmp
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