Analytical Scientist

Description

• Support method transfer activities between internal teams and external partners.
• Provide technical insights for complex analytical challenges, including root cause analysis for deviations and out-of-specification results.
• Support audit readiness and contribute to maintaining a robust quality culture.
• Design, develop, and validate analytical methods for compounded pharmaceutical products and small-molecule drug substances and products.
• Maintain compliance with cGMP and industry standards for laboratory operations.
• Collaborate with Quality Assurance on investigations and corrective actions.
• Work at the bench as needed to execute laboratory studies and support project timelines.
• Identify and implement process improvements within QC workflows to enhance efficiency and compliance.
• Develop methods for impurity profiling, degradation studies, and stability testing.
• Participate in CDMO development projects, contributing analytical expertise to formulation and process development.
• Ensure analytical methods and documentation meet regulatory requirements for FDA submissions and CMC packages.

Requirements

• Empathetic leadership skills and an understanding of diverse employee backgrounds.
• Strong knowledge of HPLC, GC, MS, dissolution, and other analytical techniques.
• Ability to mentor and coach others, with potential to lead teams.
• Minimum 10-15 years of experience in analytical method development and validation within a pharmaceutical environment.
• Diverse experience with various drug product types, APIs, intermediates, small-molecule, and compounded pharmaceuticals.
• Integrity, transparency, and a collaborative approach to decision-making.
• Excellent technical writing skills.
• Familiarity with compounding operations and small-molecule development preferred.
• Understanding of regulatory guidelines (FDA, ICH) and cGMP standards.
• Bachelor’s or advanced degree in Chemistry or a related field.

Benefits

• Employee Assistance Program
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Transportation benefits
• Medical, dental & vision
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Maryland Heights,MO. Application Deadline This position is anticipated to close on Dec 23, 2025.
• Health Spending Account (HSA)
• Short and long-term disability
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance