Principal Scientist I, Biologics Analytical CMC Strategy

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

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.