Principal Research Scientist II Full-time

Group Leader, Pdst Toxins

The Pdst 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, Pdst 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 Pdst 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.

Qualifications:

• Bachelor's Degree in Science related field with 16 years of related work; Master's 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.

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, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

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