Purpose:

The PDS&T Toxins group within Product Development, Science & Technology - Biologics organization supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial biological toxin products at AbbVie. We have an exciting opportunity for an innovative and motivated individual to join us as a Group Leader based in Irvine, CA reporting to the Director, PDS&T Toxins.  

Responsibilities

• Manage the protein characterization group by working with a group of senior and principal scientists to ensure efficient day-to-day group operation; high-quality data generation and interpretation to drive the growing product and process understanding required as part of neurotoxin development.
• Drive group performance by setting clear objectives, monitoring progress, and ensuring the consistent achievement of team goals, while actively creating development opportunities to motivate and support a high-performing team.
• Lead CQA assessment and relevant characterization studies (e.g., forced degradation study, and protein structure elucidation) for a comprehensive understanding of the product structure-function relationship.
• Lead CMC analytical development with in-depth knowledge of a broad range of analytical techniques for biologic products.
• Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries.
• Provide technical leadership for agency inspections, inquiries, and audits.
• Contribute to the operation strategy development in PDS&T Toxins; foster close collaboration within the department and across functions for effective execution of department goals
• Partner closely and effectively with diverse groups and maintain strong working relationships with internal, global, and external collaborators.
• Identify and drive continuous improvement initiatives and implement new technologies that will contribute to future business developments and improvements.

Preferred Qualifications:

• BS, MS, or PhD in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Biophysics or closely related field with typically 16+ (BS), 14+ (MS) or 10+ (PhD) years of pharmaceutical industry experience.
• Proven track record in late phase development, commercialization, and life cycle management of biologic products.
• Strong knowledge of CMC analytical and standards, such as CQA assessment, analytical control strategy, and specification setting. In-depth expertise of a broad range of biological, biochemical and biophysical methods for biologic characterization. Proven track record of leading protein analytical characterization and enabling problem-solving in sophisticated situations or for complex modalities
• Previous experience in people management is required. The ideal candidate values diverse perspectives, fosters innovation, and successfully transforms ideas into reality.
• Excellent interpersonal and oral/written communication skills, and advanced technical writing for technical documents and submissions.  Extensive experience in authoring regulatory filing and addressing health authority questions.
• Must have a “results-oriented” work ethic and a positive “can-do” attitude with a strong sense of urgency and self-motivated desire to achieve common business goals.
• Ability to work effectively cross-functionally in anticipating and responding to overall program development needs.
• Demonstrated record of independent thought, creativity and scientific accomplishment.