Director, Early Phase Analytical Development - AbbVie

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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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-Early Phase group within AbbVies Lake County (North Chicago headquarters) and AbbVie Bioresearch Center (Worcester, MA) sites. 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 -Early Phase 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 (Discovery, 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 screening through Phase 1 clinical studies.


• Ensures alignment of analytical development concepts with Early Biologics Excellence playbook and contributes to the continued improvement of analytical acceleration levers.


• Partners with Development Science functions to select appropriate biologic candidates for development and to continuously improve the Biologics Screening Funnel requirements.


• Provide leadership and talent development for 10+ analytical scientists in Early Phase 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 talents via coaching and mentoring and assures 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.


• Ensures adequate support of multiple assigned CMC projects and contributes to project prioritization on a portfolio level.


• Proactively supports Biologics CMC Development Management of plans and risks through regular communications and periodic reviews throughout clinical development.

Qualifications

• BS (18+ years); MS (16+ years) or PhD (10+ years) in Chemistry, Chemical Engineering, Biochemistry, or Biology with 8+ years of previous work experience in a laboratory setting. Previous supervisory experience required (4+ years).


• Proven experience in leading a biologics drug substance and/or drug product development organization across different levels and different scientific disciplines.


• Experience in bioanalytical methodology (SEC, CEX, CE-SDS, icIEF, KF, UV-Vis, etc.). Experience in analytical characterization for biologics using LC-MS and other advanced technologies is preferred.


• Statistical knowledge and experience are preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies. Experience in ELN preferred.


• Understands the various scientific disciplines needed in pharmaceutical development of biologics drug product (analytical, manufacturing, QA, supply chain, regulatory, etc.).


• Negotiation, conflict management, strong communication skills in fast moving environment.


• Evidence of multiple successful drug product leadership experiences at different stages of clinical development.


• Possesses negotiating, influencing, leadership skills.


• Creative in implementing entrepreneurial thinking and making smart business decisions.

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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.

• 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 Company's 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 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.