Director, PDS&T– Analytical Science ( Onsite-North Chicago, IL )

Department Description

AbbVie Product Development Science & Technology -Analytical Sciences is a global analytical science organization responsible for all CMC analytical activities related to the clinical development and commercialization of AbbVies pharmaceutical and other scope includes AbbVies diverse pipeline of innovative small molecule medicines including New Chemical Entities (NCEs) Antibody Drug Conjugate (ADC) drug linkers peptides and oligonucleotides and spans from clinical development to commercial product are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVies pipeline of innovative medicines and ensure the commercial manufacturing success.

Job Description: 

The Director will be responsible for leading a diverse team supporting AbbVies pipeline which includes novel NCEs and peptides. He/she will lead the group 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.

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.

Major Responsibilities:

• Provides leadership strategic guidance and talent development for a group 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.
• Manages and develops scientific talent 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 masters 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.
• 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 :

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. Salary: $156000- $296500

• 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 Companys sole and 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. 

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Work :

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