Principal Scientist I, PDS&T Analytical CMC Development

AbbVie; Worcester (MA); On-site; USD 125,000 - 237,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Worcester, MA seeks a Principal Scientist I for PDS&T Analytical CMC Development. You will drive analytical control strategy for late-stage biologics and lead cross-functional teams to deliver robust method development, validation and regulatory support.

The role requires strong technical expertise in biologics analytics, strategic thinking, excellent communication, and collaboration across process development, regulatory and quality. A BS/MS/PhD with extensive experience is expected.

Qualifications

• Experience in analytical control strategy development for biologics.
• Strong communication and collaboration across process development, regulatory and quality.
• Demonstrated ability to lead analytical sub-teams and present data clearly.

Responsibilities

• Drive analytical control strategy and justification of specifications.
• Establish cross-functional collaborations to deliver analytical BLA enabling activities.
• Lead analytical sub-teams and translate objectives into actionable activities.
• Interpret data trends in release and stability assays.
• Communicate project strategy, issues, and risks to teams and escalate when needed.

Skills

Analytical development

Biologics analytics

Cross-functional leadership

Education

Bachelor's or equivalent in a relevant field

MS in a related field

PhD in a related discipline

Tools

none

Job description

Principal Scientist I, 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 AbbVie

AbbVie'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 AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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 Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation 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/visioninsurance and 401(k) to eligibleemployees.

This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat 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 withapplicable 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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