Sr. Principal Scientist, Analytical Development

Role Summary

Lead a sub-team in analytical development and/or serve as analytical lead for multiple projects to guide analytical activities supporting drug substance and drug product development from preclinical through commercial phase. Develops, establishes and validates testing methods used to control raw materials, in process testing, intermediates, API and drug products. Responsible for development and implementation control strategies, with special emphasis on advancing innovation in analytical techniques. Responsible for keeping work in compliance with cGMP, safety and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.

Responsibilities

• Leads and manages multiple projects. Represents Analytical Development on cross-functional teams. Maintains accountability for analytical deliverables and progress on CMC plans for all development projects
• Manages designs, plans and executes activities towards the goals of one or more analytical development projects to support pre-clinical through commercial activities
• Directs laboratory work and/or lab personnel and ensures safe laboratory practices
• Performs analytical development and optimizes methods in support of preclinical through commercialization
• Creates and implements novel ideas and techniques to support analytical activities with Chemical and Product Development
• Develop and support off-site analytical transfers, manufacturing support and interaction with contractors
• Supplies input into CMC regulatory documentation and supporting work
• Facilitates effective supervision of laboratory personnel and guidance for their professional development
• Leverages literature, ICH/ Regulatory guidance, and practical experience to perform their work and influence CMC strategies
• Contributes to development of policies and department strategies
• Builds and enhances internal and external professional relationships
• Supports career development and technical growth of direct reports
• Presents finding at varying levels across the company
• Other duties as assigned

Qualifications

• BS/BA in Analytical Chemistry or related discipline and 15+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR
• MS/MA in Analytical Chemistry or related discipline and 13+ years of experience OR
• PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience
• Expert knowledge and understanding of analytical chemistry and a thorough understanding of process chemistry as well as formulation development
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent laboratory and productivity skills
• Method development, validation, and transfer experience in Analytical Development
• Comprehensive understanding of cGMP requirements in API and drug product
• Expert knowledge of cross-functional understanding related to drug development
• Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
• Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects
• Leads the development of intellectual property
• May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on division/company
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management, strong project leadership skills