Director, Biologics Analytical R&D

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Job description

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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description
The Biologics Analytical R&D (ARD) group develops antibody drug conjugates (ADC) and other therapeutic biologic medicines by developing analytical methods and providing analytical results to support drug substance and drug product process and formulation development. Biologics ARD partners with all functions across Biologics CMC to deliver high-quality drug products for patients.

The Director, Biologics ARD will lead the Analytical Development group within AbbVies Lake County (North Chicago headquarters) site. He/she will have complete accountability for the multiple pipeline projects, development of relevant science and technology, people management and organizational development, and implementation of functional strategies. He/she will ensure that the functions deliverables are completed within established timelines, budgets, resource allocation and in accordance with regulatory, quality, and safety requirements.

This position is based at our Lake County headquarters in North Chicago, IL.

The Ideal Candidate Will:

• Use a breadth of experience to drive phase-appropriate analytical development strategies to support AbbVies early phase pipeline through leadership and scientific expertise for the Analytical Development - group.
• Drive alignment for early-phase biologics development across Biologics Analytical R&D and partner with department subfunctions to meet the Early Biologics Excellence milestones.
• Develop and implement early-phase analytical development strategies for Biologics Analytical R&D. Advance early-phase analytical development concepts fit for purpose to the growing and diversifying discovery biologics portfolio.
• Effectively manage organizational interfaces (Small Molecule CMC, Biologics CMC, CMC RA, Ops S&T and QA).

Key Responsibilities Include:

• Accountable for early analytical method development and appropriate control strategies from candidate nomination through Phase 1 clinical studies/clinical proof of concept.
• Ensures alignment of analytical development concepts with Early Biologics Excellence playbook and contributes to the continued improvement of analytical acceleration levers.
• Provide leadership and talent development for 20+ analytical scientists in Analytical Development.
• Adapt to changing environments and balances priorities within Biologics Analytical R&D and ensures utilization of appropriately science-based approaches to ensure project and internal/external budget success and increase efficiency.
• Drive technological innovation and guide improvements to leverage scientific and operational excellence within Biologics Analytical R&D and in line with the Biologics CMC Development/AbbVie strategy for NBEs.
• Recruit, promote, and retain top talent via coaching and mentoring and assure effective succession planning.
• Promotes entrepreneurial thinking and makes smart business decisions while balancing risk.
• Proactively leads interfaces with other functions inside and outside of Biologics CMC Development and R&D.
• Assures compliance with AbbVie safety, quality and regulatory policies and government regulations.

Qualifications

• BS (18+ years); MS (16+ years) or PhD (10+ years) in Chemistry, Biochemistry, or Biology with 8+ years of previous work experience in a laboratory setting. Previous supervisory experience managing large teams required (4+ years).
• Proven experience and understands the various scientific disciplines needed in pharmaceutical development of biologics drug product (analytical, manufacturing, QA, supply chain, regulatory, etc.).
• Evidence of multiple successful analytical leadership experiences at different stages of clinical development.
• Experience in analytical methodology (HPLC, KF, UV-Vis, etc.). Experience in bioanalytical techniques including SEC, CEX, CE-SDS, icIEF, and subvisible particle analysis for biologics is preferred.
• Possesses experience working in a GMP laboratory setting, clinical batch release, designing/managing stability studies, CAPA, method development/validation, and regulatory authoring.
• Statistical knowledge and experience are preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies. Experience in ELN preferred.
• Possesses negotiating, influencing, leadership and strong communication skills in a fast-moving environment.
• Creative in implementing entrepreneurial thinking and making smart business decisions.

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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 AbbVies 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.

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