Associate Director, Technical PDS&T

Company Description

Abb Vie'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 including immunology, oncology, neuroscience, and eye care, along with products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

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  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.

• 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.

• 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.

• Bachelors Degree in Science related field with 16 years of related work;
  Masters Degree Science or PharmD with 14 years of related work;
  PhD in Science or related field with 8 years of related work experience.
• Proven ability to innovate with a history of new or improved product releases.
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.

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 this posting based on the job grade for this position. Individual compensation paid within this range will…