Job description
We are seeking a Senior Analytical Chemist to join our Cambridge-based team at ApexChem Labs. This role focuses on method development, validation, and routine QC analyses within a fast-paced pharmaceutical chemistry environment. You will collaborate with cross-functional teams to ensure data integrity, regulatory compliance, and timely delivery of high-quality results.
Ideal candidates bring a track record of analytical excellence, strong problem-solving abilities, and a passion for scientific rigor. If you thrive in a collaborative, innovation-driven culture, this is your opportunity to make a meaningful impact on drug development and quality assurance.
Responsibility
- Lead method development, optimization, and validation for analytical methods (HPLC/UPLC, GC, MS) to support drug development and release testing.
- Perform quantitative analyses, data interpretation, and troubleshooting to ensure accuracy, precision, and traceability.
- Author and maintain GMP-compliant SOPs, validation protocols, and change controls; prepare clear and concise technical reports.
- Collaborate with R&D, QA, and manufacturing teams to investigate deviations and implement effective CAPAs.
- Ensure regulatory compliance with FDA/ICH guidelines; uphold data integrity and audit readiness across all analyses.
- Oversee instrument maintenance, calibration, qualification, and timely troubleshooting of analytical hardware.
- Mentor and train junior analysts, supporting development of a high-performing analytical team.
Qualification
- MS or PhD in Chemistry, Analytical Chemistry, or a closely related field; 3+ years of hands-on analytical chemistry experience in a regulated environment (pharma/biotech/CRO).
- Proficiency with HPLC/UPLC, GC, MS, FT-IR, UV-Vis, and quantitative analytical techniques; experience with method development and validation.
- Strong knowledge of GMP/GLP, regulatory documentation, and quality systems; experience with CQAs and IQ/OQ/PQ activities.
- Experience with data integrity, statistical analysis, and software tools (LIMS/ELN, ChemDraw, Instrument control software).
- Excellent problem-solving, documentation, and communication skills; able to work effectively in cross-functional teams.
- Detail-oriented, with strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.
- Demonstrated commitment to safety, quality, and continuous improvement; professional certifications (e.g., CQE) are a plus.