Scientist II: Analytical Chemistry (HPLC/MS and GC/MS)
Job Description:
We are seeking an experienced Scientist II to join our team. In this role, you will be instrumental in ensuring the quality and safety of our clients' pharmaceutical products. Your expertise in HPLC/MS and/or GC/MS instrumentation, along with experience in cGMP method development and validation, will support our mission of providing industry-leading analytical testing services.
Responsibilities:
Adhere to all applicable current Good Manufacturing Practices (cGMP) regulations and laboratory safety standards.
Perform extractable and leachable testing for drug products, manufacturing components, and medical devices in accordance with cGMP guidelines.
Develop, validate, and optimize analytical methods for extractables and leachables using HPLC/MS and/or GC/MS.
Author technical documents such as test methods, protocols, reports, and procedures.
Conduct technical reviews of data and reports generated by other scientists to ensure accuracy, completeness, and compliance with specifications and procedures.
Troubleshoot, maintain, and implement new analytical instruments, including LC/MS and GC/MS.
Collaborate with cross-functional teams to ensure adherence to Good Manufacturing Practices (GMP).
Qualifications:
Bachelor's degree in chemistry, analytical chemistry, or a related field; an advanced degree is preferred.
Minimum of 3 years of hands-on experience in HPLC/MS and/or GC/MS method development and validation within a GMP environment.
Strong expertise in chromatographic techniques, including method development, troubleshooting, and data interpretation.
Familiarity with software such as MassLynx, Agilent OpenLab CDS, and waters_connect UNIFI is preferred.
Excellent verbal and written communication skills.
Detail-oriented, self-motivated, and capable of working effectively in a team environment.