Senior Scientist, II CMC Sciences Biologics Development and Launch (BDL) -Remote Role

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