Senior Scientist II - Analytical Development

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, and neuroscience—and products and services in our Allergan Aesthetics portfolio.

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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 Abb Vie’s Biologics to support product and process development for early‑phase, late‑phase, and commercial programs. Techniques/methods utilized include ELISAs, surface plasmon resonance using Biacore, and qPCR.

The role involves managing all analytical aspects of biologics products on the market, overseeing commercial methods throughout their lifecycle—from method transfer and performance monitoring to troubleshooting and enhancement. The individual will also play a key role in establishing commercial product specifications, stability programs, and regulatory filings, collaborating with other analytical teams, process development, global QC, and manufacturing science and technology groups.

• 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—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.
• Experience with 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.

• Base pay range is provided as a guideline; final compensation is dependent on geographic location and other factors.
• We offer a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
• This job is eligible to participate in our long‑term incentive programs.

Note:

No amount of pay is considered wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion until paid and may be modified at the Company’s discretion.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community.

US & Puerto Rico applicants seeking a reasonable accommodation:
You may request accommodation through our internal platform.