Principal Research Scientist I -( On-site Irvine, CA)

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

The Toxins group within the Product Development, Science & Technology (PDS&T) - Biologics organization supports manufacturing, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxins products at AbbVie. We have an exciting opportunity for a group leader position based in Irvine, CA reporting to the Director of PDS&T Toxins. The Toxins group within the Product Development, Science & Technology (PDS&T) - Biologics organization supports manufacturing, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxins products at AbbVie. We have an exciting opportunity for a group leader position based in Irvine, CA reporting to the Director of PDS&T Toxins.

• Lead team in analytical assay transfer, development, optimization and validation for biological toxin products, following ICH guidelines. Focus areas include HPLC, CE, iCIEF, ELISA, and qPCR. Ensure compliance and consistency of method validation practice within the organization.
• Provide analytical support for troubleshooting in GMP manufacturing and QC testing.
• Provide analytical support for process development and improvement, process characterization and validation.
• Manage laboratory operations to ensure lab safety and compliance with EH&S requirements.
• Support building analytical laboratory capability for method development, validation, and testing support.
• Author and review CMC analytical sections of BLA and other CMC regulatory packages, such as analytical methods, specifications, analytical comparability, and elucidation of structure, and stability assessment. Develop strategies for addressing health authority inquiries. Provide technical leadership for agency inspections, inquiries, and audits.
• Communicate and present analytical development topics in cross-functional CMC meetings.
• Identify and drive continuous improvement initiatives and implement new technologies that will contribute to future analytical improvements.
• Partner closely and effectively with diverse groups within function and maintain strong working relationships with internal, global, and external collaborators.

Qualifications

• BS, MS, or PhD in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or closely related field with typically 14+ (BS), 12+ (MS) or 5+ (PhD) years of industry related experience.
• Ability to work with select agents in accordance with all relevant safety and compliance regulations
• Must have a "results-oriented" work ethic and a positive "can-do" attitude with a strong sense of urgency, self-motivated, and the ability to lead a team to achieve common business goals.
• Proven track record in late phase and commercial assay development and validation, and life cycle management of biologic products.
• Demonstrated hands-on experience in developing HPLC/UPLC, CE, ELISA, qPCR, and icIEF methods for biological products
• Demonstrated extensive experience in assay validation in accordance with ICH guideline.
• Extensive experience in analytical method transfer and supporting QC troubleshooting.
• Extensive knowledge and experience working in a cGMP environment
• Excellent interpersonal and oral/written communication skills, and advanced technical writing for submissions. Extensive experience in regulatory filing and addressing health authority questions.
• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.

Additional Information

Applicable only to applicants