About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

As themAbleadfor clinical programs, thispositionwillbe responsible forsupportingregulatory approval of biologics drug substances by leading technical teams throughout Phase 1, Phase 2, and Phase 3 developmentand authoring Chemistry, Manufacturing, and Controls (CMC) filing content.

Responsibilities:

• Accountable for driving CMC development plans in collaboration withtechnicalfunctions and in alignment with overall programobjectives.
• Ensures technical rigor andis accountable for team performance and technical deliverables of the project.
• Leads technical issue resolution and implements robust solutions that are aligned cross-functionally.
• Ensures phaseappropriate controlstrategy based on timelines and project risks.
• Schedulestechnical teammeetings, develops agendas,issuesprogramhighlights, and drives project timelines to ensure successful process development and regulatory submission.
• Works with thefunctional area leadstoassemblecontent for technical reviews.
• Apprises CMC andPDS&T management of plans and risks through regular communications and periodic reviews throughout development.
• Responsible for the preparation and review of regulatory filings. Respondsto 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.
• Managesprojectsutilizinga matrix management approach.

• Bachelors degree with at least 14 years of relevant experience;Masters Degreewith 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.
• Mustdemonstrateexcellent scientific writing and verbal communication skills, including experience authoring technical and regulatory documentation.
• Prior experience must include leadership in technical roles anddemonstratedability of problemsolving ondifficult technical problems.
• Prior experience working in highly matrixed teams anddemonstratedleadership skills to influence and guide teams in achieving CMC deliverables while balancing scientific, quality, and compliance requirements.
• Strong project management skills withabilityto manage multiple programs.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html