Biologics Analytical R&D Lead

BioSpace; North Chicago (IL); On-site; USD 150,000 - 230,000; Full time

Job summary

AbbVie Biologics ARD in the United States is seeking an analytical lead to define strategies for formulation and process development studies, guiding analytical development from discovery through clinical readiness.

You will collaborate with cross-functional teams and external laboratories to ensure timely method development, validation/transfer, and testing of clinical supplies, delivering robust data for regulatory submissions.

Qualifications

• Strong background in analytical development for biologics (CMC)
• Ability to design and implement robust analytical strategies
• Experience coordinating with external labs and regulatory teams
• Proven track record in data interpretation and decision making

Responsibilities

• As analytical lead, develop analytical strategies and communicate to Analytical R&D functions and CMC business partners for experimental execution in support of stability studies, product analytical control strategies, comparability studies and extended characterization of biologics.
• Collaborate with third party laboratories to ensure CMC timelines are met.
• Interpret and identify data trends in key analytical release and stability assays.
• Author and/or review key regulatory documents, laboratory data, technical memos and reports.
• Proactively advise and share knowledge/expert opinions with peers and senior management. Mentor peers in project management and development of analytical strategies.
• Demonstrate scientific excellence in analytical characterization of biologics internally and externally and build and foster an active network of consortia collaborations
• Brainstorm ideas for continuous improvement activities and lead/participate in initiatives.
• Understand and adhere to corporate standards regarding

Skills

Analytical leadership

Cross-functional collaboration

Regulatory documentation

CMC concepts

Job description

AbbVie Biologics ARD in the United States is seeking an analytical lead to define strategies for formulation and process development studies, guiding analytical development from discovery through clinical readiness.

You will collaborate with cross-functional teams and external laboratories to ensure timely method development, validation/transfer, and testing of clinical supplies, delivering robust data for regulatory submissions.