Senior Scientist, I- Analytical Development ( On-site-Worcester, MA)

We are seeking a highly motivated Senior Scientist I 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 AbbVies Biologics to support product and process development for earlyphase latephase 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 crossfunctional multisite 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.

Qualifications :

• Bachelors Degree or equivalent education and typically 10 years of experience Masters Degree or equivalent education and typically 8 years of experience PhD and no experience necessary.
• 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 problemsolving skills.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits 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 shortterm incentive programs. 

• This job is eligible to participate in our longterm incentive programs

Note: No amount of pay is considered to be 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 employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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