AbbVie Biologics Drug Product Development Expert with Project Management Experience (m/f) in Palatinate, Germany

Description:

Your Responsibilities:

  • Leads cross functional teams and associated pharmaceutical development activities within NBE Pharmaceutical Sciences Ludwigshafen
  • Represents all NBE Pharmaceutical Sciences Ludwigshafen CMC functions as single point of contact for assigned projects in local and global project teams
  • Plans and coordinates all drug product development activities including analytical development, formulation and process development , being responsible for project execution
  • Authors Drug Product CMC regulatory documents, responsible for appropriate quality and risk management
  • Translates functional development concepts into actionable strategies
  • Understands and efficiently communicates project status and risks, presents data and strategies adequately
  • Establishes and applies phase appropriate Drug Product CMC development concepts and standards in a resource responsible manner
  • Provides resource estimates per project based upon established cost models
  • Promotes harmonized development strategies across Biologics Drug Product projects and sites
  • Identifies and promotes opportunities to further streamline CMC development activities across relevant interfaces and partner functions globally
  • Drives the incorporation of knowledge of current regulations, guidances and competitive environment into decisions and strategy

Qualifications:

Your Profile:

  • University degree in natural science or business related or equivalent is required - Advanced degree preferred
  • At least 8 years of experience in pharmaceutical development or operations or related field, demonstrated expert knowledge in more than one discipline preferred
  • At least 6 years of supervisory or management experience in technical individuals or programs in different clinical phases
  • Experience in project and budget planning and execution
  • Demonstrated communication and negotiation skills in English
  • Experience in a cross-functional, global environment, where interactions with other, equally talented individuals requires technical expertise, negotiating skills and diplomacy
  • Excellent understanding of both scientific and regulatory requirements in the area of responsibility

We are looking forward for your application. Please give us information about your salary expectations and possible start date in your motivation letter.

An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.

Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: Germany-Rhinland-Palatinate-Ludwigshafen
Organization: Research & Development
Schedule: Full-time
Shift: Not required
Travel: Yes, 5 % of the Time
Req ID: 1606824