Senior Scientist II / Principal Scientist I

Analytical Lead is responsible for project planning and execution of analytical activities to successfully drive pipeline and life cycle management NBAS projects. Internal and external analytical development functional teams and associated analytical development activities within NBAS and at CROs/partner organizations.   

Major Responsibilities:

• Coordinates all analytical R&D activities related to assigned development neurotoxin projects
  • Scientifically leads, and guides the work of analytical teams to ensure successful and timely execution of NBAS project development activities and at third party contract labs
  • Oversees and coordinates stability studies, shelf life justification, retest, change control, and reference standard qualification
  • Manages method qualification, robustness, transfer, and validation
  • Interpret analytical data and conclude quality relevant parameters
  • Manage interaction with CROs and partner organizations; ensures SMEs are brought together as needed
  • Authors NBAS analytical 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
     
• Represents NBAS Analytical as single point of contact for assigned project in local and global teams
  • Responsible for appropriate analytical quality and risk management by closely working with QAs and QC in DS and DP
  • Promotes harmonized analytical development strategies across NBAS projects and sites
  • Identifies and promotes opportunities to further streamline development activities across relevant interfaces and partner functions globally
  • Establishes and applies phase appropriate scientific concepts, business workflows and standards for assigned projects in a resource responsible manner
     
• Delivers state of the art product analytical development concepts meeting regulatory expectations to promote neurotoxin program development
   
• Drives the incorporation of knowledge of current regulations, guidance’s and competitive environment into decisions and strategy
   
• The position requires the individual to work with select agents and toxins access (i.e. Biosafety level 2 laboratories). This position is not lab-based but will require the access to and use of select agents regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

Qualifications:

• MS +7 years, or PhD +4 in biopharmaceutical sciences is required - Analytical chemistry or equivalent is preferred; Advanced degree preferred 
• Can hire senior scientist II (MS +7 years or PhD +4 years in biopharma experience) or principal scientist I (MS +10 years or PhD +6 years in biopharma experience), depending on candidate’s experience
• Strong analytical and problem-solving capabilities and skills in analytical techniques. Must be familiar with separation techniques (RP, SEC, HIC, IEX), gel and capillary electrophoresis (SDS-PAGE, CE, cIEF), mass spectrometry characterization techniques, cell-based bioassays, ELISA, immunoassays, and biophysical-based methods (UV, FLR, CD, AUC, DSC)
• CMC development experience in different clinical phases required – Phase 3 and regulatory filing experience preferred
• Knowledge in cGMP regulations and hands-on cGMP experience are desired.
• Experience in project planning and execution
• 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
• Demonstrated communication skills in English

Key Stakeholders:

• NBAS functional management and SME´s
• CMC Teams and CMC Development Program Directors
• Technical Writing Leads, Regulatory leads, Drug Substance Leads and Drug Product Leads, QA, and QC
• Line Management