Senior Scientist

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 or local law:
• 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 long-term incentive programs.
• 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

Benefits

Additional Information

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.

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