Group Leader, Sr. Group Leader, Analytical Development

The Group Leader / Senior Group Leader will lead a team of R&D analytical scientists (AAS, AS/BS, MS, PhD) in the development and validation of new analytical test methods for Company's new drug substance and drug product candidates. They will be accountable for the teams testing required for drug substance and drug product process development, characterization of impurities, and other activities associated with GLP Toxicology and cGMP Clinical Trial materials. They will provide career and technical mentoring for the teams individuals. This position reports to the Director of Analytical Development.

Responsibilities

• Works independently and/or as part of a team to meet project timelines and deliverables
• Leads a team of R&D Analytical Scientists including managerial duties like goal setting, performance feedback and talent development Provides leadership and mentoring (technical and career development guidance) to AD scientists; Works collaboratively with team members to construct and track personal annual goals and completes HR requisite documentation and reviews.
• Is a Subject Matter Expert (SME) in various analytical techniques required for method development/validation in support of drug substance and drug product development
• Builds team proficiency in the practice of method development and validation in support of drug substance and drug product projects in development and manufacturing
• Proactively problem solves and provides clear direction for team members
• Prioritizes the teams workload consistent with individuals training and expertise that are aligned with departmental priorities
• Leads the development and validation of test methods, Certificate of Analysis, Summaries of Results, Departmental Memo of Results, etc. for raw materials, in-process and isolated intermediates, final drug substances and drug products
• Leads the development and execution method validation protocols as well as the construction of requisite reports
• Makes sound scientific decisions and serves as back-up to upper management
• Stays current with new and emerging analytical techniques related to Company's products
• Represents the AD function on project teams and collaborates with cross-functional partners to ensure project deliverables and timeline expectations are met.
• Works collaboratively with cross-functional teams (Process Development, PM, QA, QC, Regulatory and others as needed) to develop and meet project goals, deliverables, and timelines
• Lead the preparation of technical reports, presentations, SOPs, WI, policies, and procedures
• Author regulatory dossier sections pertaining to CMC Analytical Chemistry
• Ensures work is compliant with cGMP and relevant regulatory requirements
• Work with third party vendors and CDMOs to assure Company's quality standards and project deliverables are maintained

Requirements:

• Ph.D. in Analytical Chemistry (or related field) with 5+ years of relevant experience; M.S. in Chemistry (or related field) with 7+ years of relevant experience; B.S. in Chemistry (or related field) with 10+ years of relevant experience
• Demonstrated expertise with analytical instrumentation theory and practice
• Demonstrated experience with pharmaceutical drug substance development and processes