Analytical Development Scientist

Responsibilities

• Perform analytical testing to support the development, validation, and control of raw materials, intermediates, and finished products.
• Execute analytical assays using both established and newly developed methodologies.
• Operate, troubleshoot, and maintain laboratory instrumentation, including HPLC, GC, GC/MS, LC/MS, FTIR, titrators, and particle size analyzers.
• Set up, optimize, and refine analytical methods for compound identification, purity determination, and potency analysis.
• Document all experimental work accurately and comprehensively in laboratory notebooks and formal reports.
• Ensure strict compliance with GMP standards, standard operating procedures (SOPs), and applicable regulatory requirements, including those related to controlled substances (e.g., DEA).
• Support the transfer of analytical methods to Quality Control and Process Support teams by preparing documentation, training materials, and technical guidance.
• Collaborate with internal teams to support Chemical Development initiatives and contribute to cross-functional project goals.
• Perform additional laboratory duties and support tasks as assigned to ensure efficient laboratory operations.

Qualifications

• Master's Degree in Chemistry with 2+ years of relevant industry experience, OR Bachelor's Degree in Chemistry with 6+ years of relevant industry experience.
• Experience supporting analytical method transfer to Quality Control or Process Support teams.
• Familiarity with DEA or other controlled substance regulatory requirements in a laboratory setting.
• Experience in API development or related pharmaceutical or chemical development activities.
• Ability to work effectively in cross-functional teams and collaborate with internal and external stakeholders.
• Interest in pursuing either a traditional scientist-level career progression or a technical specialist track.
• Comfort working with multiple analytical platforms and adapting to new technologies and methods.