AbbVie

Director, Analytical R&D, NBE

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 21, 2020
Ref
2006784
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

AbbVie Analytical Research & Development (Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of innovative small molecule and therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We 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 AbbVie's pipeline of innovative medicines. Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies. We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.

The new biologic entities (NBE) analytical development group develops state-of-the-art analytical techniques for the characterization of antibody drug conjugates (ADC) and other novel biologics.

We are looking for a multidiscipline expert to oversee Analytical Development & Operations (ADO) for NBE Lake County (LC). The candidate will act as a matrix leader with intercultural awareness and a highly collaborative attitude for multi-site/culture analytical project governance while driving global alignment between NBE development sites, with partner Analytical R&D functions and global analytical partner organizations. The candidate will develop a long term operating plan for ADO LC, manage activities within approved external budget, and will act as a scientific mentor for junior scientists.

Section I: Major Responsibilities
  • Lead a team of analytical leads responsible for 10+ early, mid and late stage development programs including highly complex projects such as liquid antibody drug conjugates (ADCs) with or without devices.
  • Defines and provides analytical strategy and deliverables (analytical control strategy and specification setting, comparability assessments, shelf-life assessment, analytical timelines and milestones) for early, mid and late stage complex development programs in alignment with ADO Director in Ludwigshafen.
  • Collaborates with and utilizes global ARD resources
  • Optimizes workflows, collaboration and governance model for multi-site/multi-functional collaboration
  • Defines, orders, oversees and tracks analytical development deliverables
  • Generates and oversees generation of ARD IND/CTA/BLA chapters for NBE programs
  • Scientifically supports due diligences and in-licensing activities.
  • Provides analytical leadership for external and partner programs.
  • Utilizes and scientifically oversees activities at CROs and newly established 10 functional service partnership FTE

Qualifications
  • BS (18+ years); MS (16+ years) or PhD (10+ years) in Chemistry, Biochemistry, or Biology with previous work experience (10+ years) in a pharmaceutical laboratory setting.
  • Preferred candidate should have broad understanding of biologics and ADC development, including mAbs, drug linker and impurity chemistry, ADC conjugation, GMP testing and analytical control strategy, primary packaging material specifics, assembled combination product specifices, and technical writing for regulatory filings
  • Implements technical and scientific concepts with demonstrated impact on multiple projects. Knows the scientific environment, sees relevant trends and proposes action to impact the business.
  • Understands the balance between business and scientific considerations.
  • Ability to translate technical concepts into clear messages for condensed strategic communication to R&D leadership
  • Strong program management skills
  • Previous supervisory experience of laboratory staff (2+ years) preferred.

Key AbbVie Competencies:
  • Interact well with diverse groups within function and maintain strong working relationships with internal and external collaborators to enable higher performance.
  • Learns fast, grasps the "essence" and can change course quickly where indicated
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experimentation for improvement
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Level and compensation will be commensurate with experience.

Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.