Analytical Lead - Internal and External Analytical Development - NBAS

Purpose Statement

• Responsible for establishing analytical development strategy for NBE programs in development
• Responsible for project planning and execution of analytical activities to successfully drive pipeline and life cycle management of NBE projects
• Represents all NBE Analytical R&D functions in global project teams

Major Responsibilities:

 

• Coordinates all NBE Analytical R&D activities related to assigned development projects
  • Scientifically leads, oversees, guides, and coordinates the work of analytical teams to ensure successful and timely execution of NBE Analytical R&D project development activities within NBE ARD and at third party labs
  • Authors NBE Analytical R&D source documents and is responsible for delivery of committed work packages of all activities assigned
  • Understands and efficiently communicates analytical project status and risks, presents data and strategies adequately
  • Assess fitness for purpose of analytical test methods for quality control and characterization; works with SMEs and Centers of excellence to interpret analytical data and conclude quality relevant parameters
  • Manages interaction with CROs and partner organizations; ensures SMEs are brought together as needed
  • Defines and Prioritizes necessary work packages

 

• Represents NBE Analytical R&D as single point of contact for assigned project in local and global teams
  • Establishes and applies phase appropriate scientific concepts, business workflows and standards for assigned projects in a resource responsible manner
  • Translates functional development concepts into actionable strategies
  • Identifies and promotes opportunities to further streamline development activities across relevant interfaces and partner functions globally
  • Aligns timeline and resource needs within NBE Analytical R&D, internal, and outside partners
  • Promotes harmonized analytical development strategies across NBE projects and sites
  • Responsible for appropriate analytical quality and risk management
• Enables learnings across programs by forcing alignment across projects and regulatory submissions
  • Establishes and continuously improves approaches related to NBE analytical development concepts across project portfolio
• Delivers state of the art product analytical development concepts meeting regulatory expectations to promote biologics development both locally and globally
• Drives the incorporation of knowledge of current regulations, guidances and competitive environment into decisions and strategy
• Recognized and sought out as an expert in discipline within the company and possibly externally

Qualifications:

• MS +7 years, or PhD +4 years in science or business related or equivalent is required - Advanced degree preferred
• Demonstrated expert knowledge and experience NBE analytical plus at least 1 more area of NBE pharmaceutical development or operations or related field
• At least 5 years of experience in supervisoring or managing programs in different clinical phases
• Strong analytical and problem-solving capabilities and skills
• Experience in project and budget planning and execution
• Demonstrated communication skills in English
• Experience in a cross-functional, global environment, used to work with teams in a matrix
• Excellent understanding of both scientific and regulatory requirements in the area of responsibility

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.