Director, Early Phase Analytical Development - #1687422

Gated Talent


Date: 1 week ago
City: North Chicago, IL
Contract type: Full time
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 AbbVie’s 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 function’s 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 AbbVie’s 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.
  • Site

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s 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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