Company Description
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 . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
Purpose:
Support regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and by leading cross-functional CMC teams throughout Phase 1, Phase 2, and Phase 3 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.
- Lead CMC teams in the development of robust control strategies and presentation of Control Strategy Reviews (CSRs)
- Drive alignment with key business stakeholders including Product Development Directors, Development Sciences, and Quality Assurance and escalate issues to senior management when appropriate
- Contribute on program acceleration and increased efficiency initiatives.
Qualifications
- BS or equivalent education in Biology, Biochemistry, Engineering or related discipline and 8+ years of experience in the biopharmaceutical industry; MS and 6+ years experience; PhD and 3+ years experience.
- Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development.
- 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.
Additional Information
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, andwemay ultimatelypay more or less than the posted range. This range may be modified in 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 to participate in our short-term incentiveprograms.
This job is eligible to participate in 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 employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at 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, visit
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: