Chemistry Scientist
Job Summary
Perform advanced chemical and analytical testing on raw materials, in-process samples, and finished products.
Execute a variety of laboratory techniques, including pH, conductivity, HPLC, GC, FTIR, titration, and other analytical methods.
Draft and review laboratory documentation such as analytical data, technical reports, SOPs, investigations, and change controls.
Review data packages for release, stability, and in-process testing to support material disposition.
Conduct statistical analysis of data, including trending and hypothesis testing.
Support validation activities including method, equipment, and software IOQ/PQ initiatives.
Develop and review protocols and reports for validation studies, assay development, and method transfers.
Operate, maintain, and troubleshoot laboratory instruments and resolve analytical issues.
Support internal and external audits to ensure compliance with regulatory and company requirements.
Ensure adherence to safety procedures, including proper handling and disposal of hazardous materials.
Aid in laboratory operations such as inventory management, equipment calibration, and housekeeping.
Collaborate cross-functionally and communicate effectively with team members and stakeholders.
Train and mentor junior staff while modeling company values and professional standards.
Contribute to continuous improvement initiatives and support CAPAs, deviations, and change control processes.
Qualifications and Need-to-Know
- Bachelor’s Degree in Chemistry or Biological Sciences.
- Minimum of 5 years of related laboratory experience in the pharmaceutical industry.
- Experience performing chemical assays and analytical testing.
- Experience with method development, validation, and laboratory instrumentation.
- Strong knowledge of USP/EP compendia.
- Working knowledge of cGMP, FDA, and regulatory requirements.
- Proficiency in Microsoft Office Suite.
- Strong written, verbal communication, and organizational skills.
- PREFERRED: Experience with TrackWise, computer system validation (ISPE GAMP), and Lean Six Sigma tools.
Pay Range
$70,000.00 - $95,000.00
Schedule
Monday-Friday 7:00am-3:30pm