This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
Work Location: Suffolk County, Massachusetts
Summary:
Lead analytical research and development for a portfolio of small molecule programs, providing strategic and technical direction from pre-clinical through late-stage clinical development. Oversee analytical method development, validation, and transfer, ensuring compliance with regulatory standards and uninterrupted clinical supply. Collaborate with cross-functional teams to deliver high-quality analytical solutions supporting regulatory filings and product advancement.
Responsibilities:
Direct analytical strategy and execution for small molecule programs across all development phases, ensuring alignment with overall objectives.
Develop and implement phase-appropriate analytical methods for drug substances and products, maintaining scientific rigor and regulatory compliance.
Manage and grow the analytical team, planning for future capability needs as the portfolio evolves.
Establish and maintain best practices for analytical lifecycle management, data integrity, and documentation.
Oversee outsourced analytical activities, including selection, onboarding, and performance management of external partners and laboratories.
Provide technical leadership in analytical method development, validation, and transfer using advanced chromatographic and spectroscopic techniques.
Ensure analytical methods and specifications are scientifically justified, phase-appropriate, and compliant with compendial and regulatory standards.
Collaborate with quality, regulatory, development, and clinical supply teams to ensure seamless integration of analytical activities into overall project plans.
Qualifications:
MS or Ph.D. in Analytical Chemistry, Physical Chemistry, or a related scientific discipline.
12–15+ years of progressive industry experience in small molecule analytical development within pharmaceutical or biotechnology settings.
Proven leadership in analytical development across multiple stages, including late-stage clinical and registration-enabling activities.
Experience managing analytical teams and executing analytical strategy.
Expertise in chromatographic and spectroscopic techniques such as GC, LC, IC, chiral separations, and detection methods (UV/Vis, CAD, MS, fluorescence, FID, ECD).
Experience managing outsourced analytical development and testing activities with contract organizations and laboratories.
Strong knowledge of global regulatory requirements and ICH guidelines for analytical development and control strategies.
Experience with complex lipophilic drug substances and enabling formulation approaches (e.g., SEDDS, soft-gel dosage forms).
Demonstrated ability to lead and influence cross-functional teams in a dynamic environment.
Excellent communication, collaboration, and scientific judgment skills.
Willingness to travel internationally up to 25% of the time.
#J-18808-Ljbffr
Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.