Senior Scientist I

Job Description

The Senior Scientist I will be an integral part of the Analytical Development team in the Operations Science and Technology Biologics Division. The role involves managing all analytical aspects of biologics products on the market, overseeing commercial methods throughout their lifecycle - from method transfer, performance monitoring, troubleshooting, to method enhancement. The individual will also play a key role in establishing commercial product specifications, stability programs, and regulatory filings. Collaboration with other analytical teams, process development, global QC, and manufacturing science and technology groups is a crucial part of this role to meet business objectives and program milestones.

Responsibilities:

Partner with Analytical Development groups to achieve commercial method readiness using traditional and advanced analytical techniques, including but not limited to HPLC/UPLC methods, gel and capillary electrophoresis, ELISA, bioassays, spectrophotometric and compendial methods.

Participate in cross-functional, multi-site, global meetings / projects and oversee commercial analytical method transfer between sites, product/process investigations, method performance monitoring and troubleshooting.

Establish scientifically sound, analytical lifecycle strategies, including methods, stability, specification and change management that meet Health Authority best practices and expectations.

Participate in the preparation and review of technical documents to ensure global compliance - including validation protocols and reports, reference standard qualification reports and analytical test procedures.

Author regulatory submissions, support regulatory inspections and provide scientifically sound responses to agency deficiency letters.

Conduct periodic review of methods and work with program leads to design, execute remediation experiments, and implement changes to new or existing commercial methods when necessary.