• Job Description

  Req#: R00128482

  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 www.abbvie.com. Follow @abbvie 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 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 short-term incentive programs.

  • 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.

  US & Puerto Rico only - to learn more, visit https://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

• About the company

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