<p>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.</p> <p>Job Description</p> <p>Purpose:</p> <p>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.</p> <p>Responsibilities:</p> <ul> <li>Accountable for driving CMC development plans in collaboration with technical functions and in alignment with overall program objectives. </li><li>Ensures technical rigor and is accountable for team performance and technical deliverables of the project. </li><li>Leads technical issue resolution and implements robust solutions that are aligned cross-functionally. </li><li>Ensures phase appropriate control strategy based on timelines and project risks. </li><li>Schedules technical team meetings, develops agendas, issues program highlights, and drives project timelines to ensure successful process development and regulatory submission. </li><li>Works with the functional area leads to assemble content for technical reviews. </li><li>Apprises CMC and PDS&T management of plans and risks through regular communications and periodic reviews throughout development. </li><li>Responsible for the preparation and review of regulatory filings. Responds to urgent regulatory queries. </li><li>Serves as spokesperson for the drug substance CMC project team on cross-functional product teams and ensures information flow among line functions. </li><li>Manages projects utilizing a matrix management approach. </li></ul> <p>Qualifications</p> <ul> <li>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. </li><li>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. </li><li>Must demonstrate excellent scientific writing and verbal communication skills, including experience authoring technical and regulatory documentation. </li><li>Prior experience must include leadership in technical roles and demonstrated ability of problem solving on difficult technical problems. </li><li>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. </li><li>Strong project management skills with ability to manage multiple programs. </li></ul> <p>Additional Information</p> <p>Applicable only to applicants</p>