Senior Scientist II - Analytical Development

We are seeking a highly motivated Senior Scientist II to join our Analytical Development team in the Product Development Science and Technology, Biologics Development Launch division. Our team is responsible for the development, qualification, and execution of analytical methods to provide product and process understanding for biological entities from discovery through commercial stages.

The successful candidate will be a part of the Biomolecular Interaction Group which is mainly focused on method development and implementation of various immunoassays to monitor process impurities and to assess potency of AbbVie’s Biologics to support product and process development for early-phase, late-phase, and commercial programs.  Some of the techniques/methods utilized in the group include 1) ELISAs to monitor and detect process related impurities; 2) surface plasmon resonance using Biacore for assessment of antigen binding and binding of antibody Fc receptors; and 3) qPCR to measure levels of residual DNA and mycoplasma. The role will  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 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.

• BS or equivalent education in Biology, Biochemistry, Engineering or related discipline and 12+ years of experience in the biopharmaceutical industry; MS and 10+ years experience; PhD and 4+ years experience.
• Industry experience in method development, qualification, validation, and method transfer in support of development and/or commercialization of biological products.  
• Methods including but not limited to ELISA, western blot, qPCR, ddPCR, SPR and automation
• Ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.