Principal Scientist , PDS&T Analytical CMC Development

• Full-time
• Salary Min: 124500
• Salary Max: 236500
• Workday Global Grade: 19
• Compensation: USD 124,500 - USD 236,500 - yearly

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. For more information about Abb Vie, please visit us at  .

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Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving the analytical CMC control strategy for late-stage development of biologics. The Analytical CMC Strategy team is responsible for ensuring late phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works cross-functionally with process development, regulatory, and quality within the Abbvie network.

This role requires a strategic thinker with a strong technical analytical background in biologic therapeutics, manage complex projects, and effectively communicate cross-functionally.

Responsibilities:

Drives overall analytical control strategy, including justifying appropriate specifications, determining critical quality attributes, assessing product shelf-life, and risk-based comparability strategies for the biologics pipeline.

Establish collaborations across the organization to ensure delivery of critical analytical BLA enabling activities.

Lead analytical sub-teams, translating development objectives into actionable analytical activities.

Interpret and identify data trends in key analytical release and stability assays.

Communicate project strategy, key issues, and risks to relevant teams and escalates risks and facilitates resolution within/across functional areas.

Actively participate in yearly FTE planning across the analytical organization

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience;
  PhD with typically 6+ years of experience in area or scientific area of discipline.
• Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies.
• Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
• Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
• Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
• Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.

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

The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.

Individual compensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

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 toparticipatein our long-term incentive programs.

Note:

No amount of payis considered to bewages 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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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.

US & Puerto Rico applicants…