Director, Biologics Analytical
About The Position
AbbVie Product Development Science & Technology – Biologics Analytical is a global analytical organization responsible for CMC analytical activities related to clinical development, commercialization, and on-market support of AbbVie’s biological products. Its portfolio includes monoclonal antibodies, multispecific antibodies, antibody-drug conjugates, gene therapies, and other biologic products, spanning clinical development through commercial product support. The Director leads diverse teams responsible for AbbVie’s biologics pipeline and commercial support. The role sets analytical strategies, develops industry-leading analytical methods and control strategies, and advances pipeline programs from clinical development through commercial manufacturing. The Director partners across functions to support robust development of drug substances, drug products, and combination products using rigorous risk management and Quality by Design principles. The Director ensures analytical deliverables meet timelines, budgets, and regulatory requirements while aligning analytical and program strategies with broader business objectives. Responsibilities include leading method development and validation strategies, implementing new technologies and automation, building productive partnerships, and managing transitions from research into late-stage clinical development and technology transfers to commercial manufacturing and testing sites.
Requirements
- PhD and at least 10 years of relevant pharmaceutical or biotechnology industry experience, or a master’s degree and at least 15 years of pharmaceutical or biotechnology experience.
- Proven experience leading a CMC development organization, such as analytical development, drug substance, parenteral products, or combination products, across a range of experience levels and scientific disciplines.
- Skill in biologics analytical method development, validation, transfer, and troubleshooting.
- Familiarity with extended characterization to evaluate critical quality attributes, assess process changes, and demonstrate biosimilarity.
- In-depth knowledge of relevant regulations and regulatory agency interactions, with substantial NDA and BLA experience and major responsibilities.
- Extensive experience and understanding of analytical control strategies, formulation development, regulatory filings, manufacturing, Quality Assurance, and supply chain.
- Demonstrated success leading strategic initiatives and evaluating and implementing new technologies.
- People-management experience and a track record leading matrix teams.
- Strong oral and written communication skills.
- Experience motivating and maintaining positive morale among highly skilled technical individuals and teams in an environment requiring compliance with standard procedures.
- Strong negotiating, influencing, and leadership skills.
Responsibilities
- Provide leadership, strategic guidance, and talent development for groups of analytical and pharmaceutical scientists supporting global development programs and commercial activities.
- Define and communicate analytical strategies for monoclonal antibodies, multispecific antibodies, antibody-drug conjugates, and other potential new modalities.
- Partner in commercial strategic initiatives involving modernization of manufacturing and quality controls.
- Lead development, validation, and transfer of analytical methods for pipeline development and product lifecycle management.
- Establish analytical capabilities supporting CMC process development, technology transfer, and post-approval changes.
- Resolve complex technical issues in an evolving regulatory landscape.
- Balance resources, resolve issues, and achieve target timing for pipeline projects and strategic initiatives.
- Ensure scientific excellence and foster the functional, scientific, and professional development of staff.
- Lead interactions with regulatory agencies in analytical development and deliver regulatory filing packages.
- Manage and develop scientific talent across disciplines and projects to address business needs.
- Drive technical excellence and scientific innovation to improve organizational capabilities and productivity.
- Collaborate across R&D and Operations to align and influence development strategies supporting drug development programs.
- Identify, evaluate, and propose internal and external collaborations to advance scientific innovation and shared learning.
- Ensure the group complies with Environmental Health and Safety regulations.
- Ensure analytical deliverables are achieved within established timelines, budgets, and regulatory frameworks.
- Integrate analytical and program strategies with broader business objectives and manage transitions into late-stage development and commercial manufacturing.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
