As a member of the Quality Control Laboratories at New England Biolabs (NEB), this individual is primarily responsible for managing transfers and routine testing at Contract Testing and Manufacturing Organizations, performing testing to support the production and release of enzymes and molecular biology reagents. The successful candidate will have expertise in liquid chromatography techniques (e.g. UPLC, UHPLC, HPLC…etc.) and capillary electrophoresis and work closely with a team of QC Analysts focused on these methods.
- Work in a team of QC Technicians
- Coordinate method transfer and qualification to CTOs and CMOs as needed
- Lead investigations at CMO/CTOs
- Manage contracts and budgets for CMO/CTO as needed
- Execute and Optimize QC test methods
- Organizing, reporting and trending test results
- Draft Quality documentation including: SOPs, test methods, protocols and reports
- Initiate and participate in laboratory and out of specifications (OOS) investigations
- Maintain the QC laboratory and associated equipment
- Maintain an up-to-date training file for the QC Department
Required Qualifications and Experience:
- B.S. degree in biology or related field
- Minimum 8 years’ experience working in a QC lab setting.
- Expertise with LC laboratory techniques.
- Have a strong knowledge of ISO 13485 and ISO 9001 Quality Management Standards and/or cGMP concepts
- The ability to perform routine tasks accurately and follow strict methodologies to carry out analyses
- Possess strong recordkeeping skills and the ability to analyze, interpret and report results to senior staff
- Strong interpersonal skills and the ability to effectively collaborate with customers and internal and external colleagues
- Have a working knowledge of MS Office applications, SAP and ELN/LIMS systems
- Ability to travel to support CMO/CTO management, up to 20%