Senior Scientist, II CMC Biologics Development and Launch

Summary

Join AbbVie as a Regulatory CMC Specialist and contribute to the approval of biologics drug substances. You will author sections of regulatory documents, lead cross-functional CMC teams, and ensure technical information is accurately transcribed. This role requires a strong understanding of biologics manufacturing processes, Good Documentation Practices, and scientific and regulatory requirements for biopharmaceutical products. You will also have the opportunity to contribute to program acceleration and increased efficiency initiatives.

Requirements

• 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

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

Benefits

• Paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k)
• Short-term incentive programs
• Long-term incentive programs