Principal Research Scientist I, CMC Sciences Biologics Development and Launch (BDL)

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

Purpose:

As the mAb lead for clinical programs, this position will be responsible for supporting regulatory approval of biologics drug substances by leading technical teams throughout Phase 1, Phase 2, and Phase 3 development and authoring Chemistry, Manufacturing, and Controls (CMC) filing content.

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 drug substance 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 years of relevant experience; Master's Degree with at least 12 years of relevant experience; or PhD with at least 6 years of relevant experience.
• Demonstrated knowledge of regulatory requirements and strong technical knowledge of biologics process and analytical development from early development through commercialization including process characterization studies, process scale-up, and technology transfer.
• Must demonstrate excellent scientific writing and verbal communication skills, including experience authoring technical and regulatory documentation.
• Prior experience must include leadership in technical roles and demonstrated ability of problem solving on difficult technical problems.
• Prior experience working in highly matrixed teams and demonstrated leadership skills to influence and guide teams in achieving CMC deliverables while balancing scientific, quality, and compliance requirements.
• Strong project management skills with ability to manage multiple programs.

Additional Information

Applicable only to applicants