Irvine, CA
9 days ago
Director, Drug Product Development, CMC Biologics

Company Description

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

Seeking a highly motivated professional to join its neurotoxin drug product development team located at Irvine, CA. This individual will play a key role in advancing the company’s innovative pipeline of neurotoxins with significant technical complexity. Reporting to the Senior Director of Drug Product Development, the individual will lead a matrixed team, providing leadership to build, operationalize, and optimize functional systems, processes, and strategies, enabling the successful advancement of early-stage projects.

Major Responsibilities:

Drive drug product projects, initiatives, and workflows, working with the formulation scientists in a matrixed structure.Oversee daily operations of the Drug Product laboratory for highly potent toxin compounds, ensuring compliance with CDC audits, and driving continuous improvement initiatives to optimize lab processes.Ensure compliance with AbbVie safety, quality, and regulatory policies, as well as relevant government regulations.Implement and manage functional processes and workflows for operational excellence. Enable increased team performance through implementing process and / or operational improvements that improve productivity and team output overall.Support operational budget management, tracking and coordinating resource demand and capacity to ensure alignment with project goals and priorities.Coordinate and communicate across multidisciplinary teams to manage complex drug product development strategies. Evaluate strengths, weaknesses, opportunities, and threats to ensure seamless project execution.Lead initiatives for continuous improvement within the Drug Product R&D organization, championing cross-functional collaboration and innovation across R&D partner functions.

Interaction, collaboration and alignment with key stakeholders in the toxin Discovery and product development area
 


Qualifications
Ph.D. and 6+, or MS Degree and 8+, or BS Degree with at least 12 years of related industry experience required. Advanced degree in Pharmaceutical Sciences, Chemistry, or Chemical Engineering is preferred.Demonstrated technical expertise in analytical, formulation, and drug product process development of biologics, with cross-functional CMC understanding to manage risk and problem-solve.Prior experience working with highly potent biologics is highly desirable.Proven experience in planning and managing complex projects with multiple functional interfaces.Experience in generating relevant regulatory sections of IND, BLA, and MAA filings.Knowledge of industry best practices and trends, with the ability to challenge the status quo and drive change.Familiarity with cGMP practices and compliance requirements.Excellent written, verbal, and presentation skills required.
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 the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and 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 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. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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