Principal Scientist/Senior Principal Scientist, CMC, Analytical Chemistry

Role Overview

• Lead a team of scientists and research associates supporting the development of New Chemical Entities drug substance and drug product for preclinical and clinical programs within the CMC group in close collaboration with the CMC teams.
• Collaborate with colleagues in Discovery to transfer product candidates into the CMC group.
• Identify and recommend analytical methodologies to support chemical development, formulation development, QC, and stability testing. Lead and perform activities related to analytical method development, optimization, troubleshooting, qualification, validation, and transfer activities for starting materials, process intermediates, drug substances, drug products, internally and at CMOs.
• Work with multi-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development, qualification/validation, and product characterization. Represent analytical function in CMC teams and interdepartmental meetings.
• Subject matter expert for impurity characterization. Track and evaluate impurity profiles for drug substance and drug product. Characterization and identify unknown impurities and their source. Develop new methods for impurity tracking.
• Resolve technical issues, review deviations and investigations at contractor sites in coordination with internal and external quality control, quality assurance, and regulatory groups, as appropriate. Provide SME technical input for OOS and OOT investigations.
• Author/review technical documents outlining analytical activities including method validation, reference standard and impurity characterization, stability, etc. Author/review analytical sections of chemistry, manufacturing and controls (CMC) sections of regulatory submissions.
• Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data, publications, and relevant benchmarking information to drive experimental design, data analysis, and functional/cross-functional strategy development.
• Keep up to date and detailed records of experiments and data analysis within an Electronic Lab Notebook system. Ensure experiments are counter-signed on a monthly basis.
• Ensure the laboratory environment is safe and well-organized; follow and keep up to date with Health & Safety policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some international travel may be required.
• Other duties as assigned.

Requirements

• Ph.D. or M.Sc. in Analytical Chemistry or closely related field with a minimum of 10 years relevant industry experience directly related to analytical development for small molecule oral drug products and drug substances.
• Expertise in HPLC, GC, LC-MS, and NMR.
• Working knowledge of CGMPs and current industry practices.
• Direct people management experience.
• Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel.
• Self-motivated individual with excellent analytical problem-solving skills, attention to detail, and commitment to providing accurate, high-quality work.
• Good organizational skills and the ability to manage multiple competing priorities.
• Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.

Benefits

• medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs
• Employee Assistance Program
• travel insurance
• retirement savings programs with company matching contributions
• vacation, personal days, sick days, and an end-of-year company shutdown
• expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees