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.

Support regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and contribute to CMC project management for monoclonal antibody development.

Responsibilities:

• Author sections of regulatory documents, including INDs and BLAs, based on relevant source documentation.
• Partner with subject matter experts in various process development functions to ensure technical information is accurately transcribed into regulatory documents.
• Complete data integrity checks on regulatory documents, including INDs and BLAs, against relevant source documentation in a timely manner.
• Contribute on program acceleration and increased efficiency initiatives.
• Apply technical knowledge to support problem-solving during process development and validation.

• BS or equivalent education in Biology, Biochemistry, Engineering or related discipline and 10+ years of experience in the biopharmaceutical industry, Master's Degree or equivalent education and typically 8 years of experience.
• Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development and validation.
• Demonstrated knowledge of Good Documentation Practices (GDP) and technical writing.
• Demonstrated knowledge of scientific and regulatory requirements for biopharmaceutical products.
• High proficiency with Microsoft Word and Excel.

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 thisposting 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 anduntil 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