Job Description

Roles & Responsibilities

• Provide analytical chemistry support and remediation for chemistry-related projects
• Participate in stability testing programs supporting process/product design changes
• Develop and validate analytical methodologies for raw materials, in-process, and finished product release testing
• Perform chemistry and performance testing, data review, and data entry
• Generate protocols and reports
• Maintain and support laboratory operations
• Troubleshoot issues and interpret instructions across written, oral, diagram, or schedule formats
• Collaborate with cross-functional teams including Regulatory, Manufacturing, and Quality

Experience Required

• 0 - 5 years overall; 2- 4 years of hands-on pharmaceutical analytical chemistry experience essential, including wet-chemistry and instrumental techniques (pH, titration, UV-Vis, GC, HPLC) and experience in an FDA-regulated/GMP environment

Skills & Certifications

• Basic knowledge of quality systems, ISO, and Medical Device standards
• Strong verbal and written communication across all levels
• Ability to work independently and within large multifunctional teams
• Excellent attention to detail and accuracy
• Strong data analysis and reporting skills (Excel proficiency; SAP preferred)
• Self-motivated, organized, and able to manage multiple priorities/deadlines
• Scientific writing and protocol/report generation skills
• Ability to discuss scientific strategies with Regulatory, Manufacturing, and Quality teams (nice to have)

Eligibilities & qualifications

• BS/MS in Chemistry, Pharmaceutics, or related science field
• Onsite role, 5 days/week
• Ability to work independently with minimal supervision

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