Analytical Chemist III

Job Description – Analytical Chemist III

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osition Summary

We are seeking an experienced Analytical Chemist III to join a growing Analytical Quality Control team supporting pharmaceutical development and manufacturing operations in a cGMP-regulated environment. This individual will play a key role in analytical method development, method validation, method transfer activities, and technical documentation while supporting both commercial and client-driven projects.

The ideal candidate is a hands-on analytical chemist with strong GMP experience, excellent technical writing skills, and the ability to work effectively within a fast-paced, collaborative laboratory environment. This role also includes mentoring and training support for junior chemists and cross-functional collaboration with Quality Assurance and other operational teams.

Key Responsibilities

• Perform analytical testing and support activities within a cGMP Quality Control laboratory environment
• Execute analytical method development, method validation, and method transfer protocols
• Operate and troubleshoot analytical instrumentation including HPLC and related laboratory systems
• Author and revise technical documents including SOPs, protocols, reports, and laboratory investigations
• Support laboratory investigations including deviations, OOS (Out of Specification), and OOT (Out of Trend) events
• Collaborate cross-functionally with QA, manufacturing, and other laboratory teams to support project timelines and client deliverables
• Maintain accurate laboratory documentation in compliance with GMP and data integrity requirements
• Participate in internal and external audits as needed
• Assist with training and mentoring junior chemists and contribute to team development initiatives
• Support continuous improvement efforts and help drive laboratory efficiency and compliance

Qualifications

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
• Minimum 7 years of analytical QC experience in a cGMP-regulated pharmaceutical or biotech environment
• Strong hands-on experience with HPLC and analytical laboratory instrumentation
• Experience executing method validations and method transfers
• Proven technical writing experience including SOP authoring and protocol/report generation
• Strong understanding of GMP documentation practices and laboratory compliance standards
• Ability to work independently while contributing effectively within a small team environment

Preferred Qualifications

• Experience with quality systems including deviations, CAPAs, OOS, and OOT investigations
• Previous audit support experience
• Experience working in a fast-paced CDMO or contract laboratory environment
• Demonstrated ability to learn new systems and processes quickly
• Strong interpersonal and communication skills with the ability to collaborate cross-functionally

Ideal Candidate Profile

• Self-starter who can operate with minimal supervision
• Energetic and adaptable team player willing to support multiple laboratory functions
• Quick learner capable of onboarding rapidly into new systems and workflows
• Strong organizational skills with the ability to manage multiple priorities simultaneously
• Passionate about supporting team success and contributing to a growing organization