Sr Associate I, Quality Control

Job Description

The Sr Associate I in Quality Control Analytical Technology (QC-AT) team is responsible for supporting quality control bioassay test method related issues at Biogen. This includes analytical method validations, transfers, and support activities for large molecule and gene therapy products in late stage clinical and commercial programs. The position requires both project management and laboratory testing. The Sr Associate I will additionally support activities related to regulatory compliance, audits, investigations, implementation of new technologies, and analyst training at Biogen and external testing laboratories.

Qualifications

• Education:BA/BS in Life Sciences with a minimum of 5-7 years, or MA/MS in Life Sciences with a minimum of 3-5 years, or equivalent advanced degree with relevant industry experience.
• Technical expertise in bioassays for potency, identification, and residual impurities with biologics and gene therapy products
• Experience with FRET, ALPHA-Screen, Octet, DELFIA, immunoassays, proliferation methods, ELISAs, and cell-based methods strongly preferred
• Required knowledge of ICH Q2 (R1) and FDA guidelines for method validation
• Broad understanding of analytical method development, optimization, and validation
• Practical knowledge and application of GMP regulations
• Demonstrated ability to perform technical writing with statistical evaluations of data
• Possess strong organizational skills with the ability to coordinate multiple concurrent activities
• Strong team player able to collaborate effectively with a diverse group on challenging projects
• Experience training laboratory analysts
• Ability to travel as needed

Additional Information

Biogen is seeking a Sr Associate I in QC-AT that has experience with bioassays and is able to provide technical support for analytical method optimization, validation, and troubleshooting.