Senior Scientist

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.

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.

Qualifications :

• BS or equivalent education in Biology Biochemistry Engineering or related discipline and 10 years of experience in the biopharmaceutical industry Masters 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.

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 thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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 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 commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time