Scientist II, Analytical Chemistry

Responsibilities

• Perform routine and non-routine testing of raw materials, in-process samples, drug substances, and finished drug products to support formulation and process development.
• Develop, optimize, and validate analytical test methods for components, drug substances, excipients, and drug products.
• Interpret and report analytical data with a high degree of accuracy and scientific integrity.
• Troubleshoot analytical methods and instrumentation, proposing and implementing effective solutions.
• Support qualification of new analytical laboratory equipment.
• Prepare technical documents including analytical method protocols, validation reports, technical reports, and SOPs.
• Prepare and maintain accurate and timely laboratory records in accordance with company policies and regulatory requirements.
• Ensure all laboratory work complies with cGMP, GLP, and company quality standards.
• Participate in cross-functional project teams and contribute to CMC documentation for regulatory submissions (IND, NDA, ANDA).
• Support method transfer and qualification activities to internal and external laboratories (e.g., CROs, CDMOs).
• Prioritize personal workload to ensure that key objectives are met on time and to budget.
• Implement continuous improvement projects that improve laboratory effectiveness and organization.
• Utilize creative thinking to generate solutions to complex technical problems.
• Support method transfer and qualification activities to internal and external laboratories (e.g., CROs, CDMOs).
• Participate in cross-functional project teams and contribute to CMC documentation for regulatory submissions (IND, NDA, ANDA).

Qualifications

• Required: Degree in a scientific field: PhD or MS with 0+ years of experience; or BS with 3+ years of experience; or 7+ years of experience without a Bachelor's degree.
• Strong attention to detail and scientific rigor.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Proficiency in analytical instrumentation and techniques including HPLC, GC, UV-Vis, FTIR, Karl Fischer, spray testing, and related analytical techniques.
• Familiarity with cGMP, ICH, and FDA guidelines.
• Competency in analytical data interpretation, documentation, and scientific reasoning.
• Strong organizational, written, and verbal communication skills.
• Ability to work independently and manage time efficiently.
• Preferred: Experience in an FDA-regulated environment.
• Experience with nasal spray drug products and devices.