Principal Research Scientist I, CMC Sciences

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

As the ADC CMC lead for clinical/commercial programs, this position will be responsible for supporting regulatory approval of antibody drug conjugates and commercial support by leading technical teams throughout late-phase and commercial development, authoring/reviewing Chemistry, Manufacturing, and Controls (CMC) filing content, and on-market support such as troubleshooting, global expansion, site-transfers, and continuous improvement efforts.

 Responsibilities:

• Accountable for driving CMC development plans in collaboration with technical functions and in alignment with overall program objectives.
• Ensures technical rigor and is accountable for team performance and technical deliverables of the project.
• Leads technical issue resolution and implements robust solutions that are aligned cross-functionally.
• Ensures phase appropriate control strategy based on timelines and project risks.
• Schedules technical team meetings, develops agendas, issues program highlights, and drives project timelines to ensure successful process development and regulatory submission.
• Works with the functional area leads to assemble content for technical reviews.
• Apprises CMC and PDS&T management of plans and risks through regular communications and periodic reviews throughout development.
• Responsible for the preparation and review of regulatory filings. Responds to urgent regulatory queries.
• Serves as spokesperson for the CMC project team on cross-functional product teams and ensures information flow among line functions.
• Manages projects utilizing a matrix management approach.

Qualifications

• Bachelor’s degree with at least 14