Commercial Analytical Technology is a global group that supports Global Quality Control with the responsibility of optimization, validation, and transfer of analytical methods in alignment with asset priorities and timelines as well as technical support of QC investigations.
Must have the ability to model the Biogen Elements (customer focused, inclusive, pioneering, agile, accountable, and ethical), and must work effectively independently, within a team framework, and across all business areas of the organization.
The position will require close collaboration with internal and external Quality Control, Analytical Development, Process Development, Product Development Quality, and Regulatory CMC.
Minimally Bachelor of Science in Biochemistry, Biological Sciences or related field and at least 10 years of industry experience.
Technical expertise in protein characterization, release and stability assays for biologics (HPLC, CE, peptide map, NIR, UV-VIS, titer analysis, etc.
Experience with statistical experimental design and data analysis using Excel and JMP software.* Excellent time management and prioritization skills.
Detail orientated and able to thrive in a fast-paced environment with competing priorities.* Practical knowledge and application of GMP regulations for biologics.
Ability to manage all aspects of analytical method optimization, validation, transfer, investigations, and GMP testing with current guidelines and in compliance with regulations (e.
g., FDA, EMA, ICH).* Demonstrated project leadership skills and ability to develop effective working relationships with internal / external sites and cross-functional project teams.
Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors, and external partners effectively.
All your information will be kept confidential according to EEO guidelines.