Job DescriptionThe Director will be responsible for leading a diverse team supporting AbbVie's pipeline which includes novel NCEs, peptides, and biologic products from natural sources. He/she will lead the groups to drive the development of industry-leading analytical methods, analytical characterization packages and control strategies to advance pipeline programs from clinical development through commercial manufacturing. He/she will partner cross-functionally to drive robust drug substance and drug product manufacturing process development by providing key analytical data and insights. He/she will advance fundamental understanding of drug release and product performance by developing the bioequivalence safe space and/or IVIVC using physiologically based biopharmaceutics modeling through close collaborations with clinical pharmacology and formulation development. He/she will lead physicochemical characterization and establishing the relationship between the compound properties and the product performance in vitro and in vivo.
The Director will ensure that all analytical deliverables are achieved within set timelines, budgets, and regulatory frameworks, while seamlessly integrating analytical and program strategies into broader business objectives. He/she will establish collaborative and productive working relationships with key partner organizations to define successful process development strategies. The Director will effectively manage interfaces to ensure seamless transition of research programs into late-stage clinical development and technology transfers to commercial manufacturing and testing sites. The Director will manage a team of scientists on multiple projects in multiple analytical development specialty areas, such as chromatography, spectroscopy, drug release, understanding drug performance relationship between in vitro and in vivo, and lab automation and digitalization
Major Responsibilities:
- Provides leadership, strategic guidance and talent development for groups of highly skilled analytical and pharmaceutical scientists who are responsible for global development programs and commercial support across AbbVie global network
- Defines and communicates industry-leading analytical strategies for NCEs, peptides and other potential new modalities
- Responsible for development, validation and transfer of analytical methods aligned with the strategies
- Establishes industry-leading analytical capabilities to support process development, formulation, technology transfer and post-approval changes
- Drives fundamental understanding of drug release and product performance and develop biopharmaceutics risk assessment based biowaiver strategies
- Solves difficult and highly complex technical issues in an evolving regulatory landscape
- Balances resources, resolves issues and achieves target timing for pipeline projects and key strategic initiatives
- Drives technical excellence and innovations in science that improve the capabilities and productivity of the organization
- Works collaboratively across R&D and Operations to align and influence a broad range of development strategies that directly support drug development programs
- Familiar with commercial manufacturing and testing and able to be a partner in strategic initiatives in the commercial space for modernization of manufacturing and controls
- Manages and develops scientific talent (20-30 Scientist, Senior Scientists, and Managers) across multiple disciplines and/or projects to address current and future business needs.
- Ensures scientific excellence and fosters functional, scientific, and professional development of staff.
- Leads interactions with regulatory agencies in analytical development area and delivers regulatory filing packages
- Identifies, evaluates, and proposes both internal and external collaborations to drive scientific innovation and shared learning.
- Accountable for compliance with Environmental Health and Safety regulations for the group.
Qualifications- PhD with at least 10 years of relevant pharma/biotech industry experience or master's degree with at least 15 years of pharma/biotech experience.
- Proven experience leading a CMC development organization with a range of experience levels and scientific disciplines.
- Skilled in physical characterization, structural elucidation and establishing relationship between compound/formulation properties and performance
- In depth knowledge in relevant regulations, interactions with regulatory agencies, and NDA and/or BLA experience with major responsibilities.
- Extensive experience and solid understanding of the various scientific disciplines, including analytical control strategies, dissolution, biopharmaceutics, formulation development, regulatory filings, manufacturing, QA, and supply chain.
- Demonstrated record of success leading strategic initiatives and new technology evaluation/implementation.
- Track record on people management experience and leading matrix teams.
- Strong oral and written communication skills.
- Experience motivating and maintaining positive morale of highly skilled technical individuals and teams in an environment where compliance to standard procedures is required.
- Strong negotiating, influencing, and leadership skills.
Additional Information• 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.
