Associate Director, Technical PDS&T

Purpose

The PDS&T 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.

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 :

Qualifications :

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 thetime of this posting 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 short-term incentive programs.

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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until 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

Key Skills

Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation

Experience : years

Vacancy : 1