Our client - a leader in contract laboratory services, regulatory guidance and supply chain assurance within the pharmaceutical and biopharma industry - is seeking a Research Chemist to join their growing team.
Type: Direct Hire
Location: Hunterdon County, NJ
Rate: $90K - $120K
Key Responsibilities:
- Lead and execute extractable studies, leachable studies, extractable-leachable correlation studies, material characterization, and mass spectrometry-based method validations.
- Perform in-depth analysis and interpretation of mass spectral data, providing expert evaluations.
- Engage with clients to discuss study designs, validation strategies, and technical inquiries.
- Offer guidance on regulatory requirements, including cGMP, CFR, USP, PQRI, and BPOG.
- Prepare comprehensive reports detailing findings from extractable studies, method validations, and correlation studies.
- Advance GC/MS and LC/MS capabilities within the organization by applying technical expertise and innovative problem-solving approaches.
- Develop and implement new GC/MS and LC/MS methodologies tailored to client needs.
- Support GC/MS and LC/MS workflows by ensuring proper operation/calibration, sample preparation, and rountine maintenance/repairs.
- Clearly convey technical insights and project progress to both clients and internal teams through written documentation and presentations.
Qualifications:
- Ph.D. in Chemistry or a related field strongly preferred (or BS degree +10 years of experience/MS degree +5 years of experience)
- Hands-on experience with GC/MS and LC/MS, demonstrated through industry or academic research.
- Strong expertise in mass spectrometry, sample preparation, and advanced analytical problem-solving.
- Proficiency in chemical structure elucidation from LC/MS data interpretation (complex ESI spectra) and GC/MS data interpretation (CI and EI spectra).
- Deep understanding of instrumentation, experimental design, and mass spectrometry data analysis.