Director, Small Molecule (Analytical)

Employer
AbbVie
Location
Lake County, IL, US
Posted
Nov 05, 2018
Ref
1806579
Required Education
Bachelors Degree
Position Type
Full time
The Drug Product Development (DPD) organization within AbbVie develops phase appropriate drug products for small molecule and antibody drug conjugate (ADC) programs, supporting pre-clinical studies through commercial registrations. We prepare GMP drug products to develop AbbVie's pipeline, and ultimately we provide commercial manufacturing processes for product launches.

AbbVie is seeking a highly motivated individual with a proven track record of leadership to serve as the Director within the small-molecule Analytical function in DPD. This individual will have strong collaborations within DPD, as well as with other R&D and Commercial Manufacturing Operations functions.

Successful candidate will have an extensive expertise in development activities associated with drug substance and drug product process development and scale up. They will have the ability to develop and communicate a clear and concise business strategy, demonstrate effective decision making, and manage and inspire their team to thrive in a dynamic environment with a specific emphasis on analytical method development and control strategies.

Primary Job Function:

  • Lead and manage analytical teams that conduct analytical research in pre-FIH through commercial registration with high scientific rigor and implementation of analytical process control strategies to advance small molecule drug discovery candidates
  • Work collaboratively with other functional areas outside Analytical to advance projects through the pipeline.
  • Support new product development with advanced method development and validations, technical transfer packages, and generation of technical data in support of clinical API and drug product regulatory requirements.
  • Ensure the development of strategies that drive scientific excellence and innovations that improve the future capabilities and productivity of the greater organization.
  • Responsible for leadership and technical development within the function generating future leadership for the function. This includes establishing a sustainable high functioning team, managing performance of the team and in conjunction with team members, developing career paths for growth.
  • Form strong cross-functional alliances across R&D and Commercial Manufacturing Operations to ensure robust and effective process development control strategies with efficient analytical technical transfer
  • Assures compliance with AbbVie safety, quality and regulatory policies and government regulations


Basic:

  • Bachelors, Masters, or PhD in Analytical Chemistry with a minimum of 16+ (BS), 14+ (MS), or 8+ (Ph.D) years related industry experience
  • Strong technical background in analytical chemistry
  • Demonstrated leadership of technical teams and effective cross-functional communication
  • Demonstrated capability to solve critical scientific and business problems.
  • Demonstrated ability to implement and to grow capabilities of an analytical organization and develop people into future leaders
  • Extensive experience in drug substance and drug product process development, scale-up from pilot plant to a commercial facility, and analytical tech transfer to R&D and QC laboratories
  • Understanding of cGMP and regulatory requirements


Preferred:

• Advanced degree in Analytical Chemistry or Pharmaceutical Sciences

Key Leadership Competencies:
  • Builds strong relationships with peers and cross functionally with partners outside of team 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


Equal Opportunity Employer Minorities/Women/Veterans/Disabled