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 applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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