AbbVie · 2 weeks ago
Associate Director, Technical PDS&T
Irvine, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$138K/yr - $261K/yr
14+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines to address serious health issues. They are seeking an Associate Director for the PDS&T Toxins group to manage protein characterization and lead CMC analytical development for biological toxin products.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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
Qualification
Required
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
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
Preferred
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
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
Genetic Engineering News
2026-01-12
2026-01-11
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