Website AbbVie
AbbVie
Company : AbbVie
Job Description
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.