
Research Chemist - Mass Spectrometry
22h22 hours agoIntertek
Whitehouse, US · Full-time · $105,000 – $145,000
About this role
Intertek Pharmaceutical Services located in Whitehouse, New Jersey, USA, is a cGMP contract testing, analytical research and development laboratory. Intertek works directly with both large and small pharmaceutical companies to help bring safe and effective pharmaceutical products to market. An opportunity has arisen for a Research Chemist to join the Trace Organics work team utilizing state-of-the-art Orbitrap instrumentation focused on extractables and leachables.
The Research Chemist will plan and execute extractable studies, leachable studies, and mass spectrometry-based method validations independently and as part of a team. Responsibilities include providing high-level evaluation of complex mass spectral data and engaging in complex conversations with clients on study design and validation questions. The role involves guiding clients based on understanding of the regulatory environment including cGMP, CFR, USP, PQRI, and BPOG.
This fast-paced, flexible environment provides direct interaction with clients to understand and achieve their needs and appreciate the potential impact on patient quality of life. The team works with an expert group of accomplished scientists focused on solving difficult technical challenges using GC/MS and LC/MS technologies. Members support safe operation of instruments, sample preparation, troubleshooting, and maintenance.
We offer coaching, feedback, on-site and off-site training, and growth opportunities to develop each employee’s career. Intertek's Chemical & Pharmaceuticals team provides regulatory guidance and supply chain assurance for pharmaceutical outsourcing requirements. Join to work with innovative companies ensuring Total Quality Assurance.
Requirements
- Expertise in Orbitrap instrumentation for extractables and leachables analysis
- Proficiency in GC/MS and LC/MS method development and validation
- Ability to interpret complex mass spectral data
- Knowledge of regulatory guidelines including cGMP, CFR, USP, PQRI, BPOG
- Experience planning and executing extractables and leachables studies
- Skills in material characterization using mass spectrometry
- Familiarity with trace organics analysis in pharmaceutical testing
- Capability to troubleshoot and maintain mass spectrometry instruments
Responsibilities
- Plan and execute extractable studies, extractable-leachable correlation studies, mass spectrometry-based method validations, leachable studies and material characterization studies independently and as part of a team
- Provide high-level evaluation of complex mass spectral data
- Engage in complex conversations with clients on study design, validation questions, etc.
- Guide clients based on understanding of the regulatory environment including cGMP, CFR, USP, PQRI, BPOG
- Write complex reports for extractable studies, extractable-leachable correlation studies and method validation studies
- Work with group members to advance GC/MS and LC/MS technology through knowledge of the field and innovative problem-solving
- Develop new GC/MS and LC/MS methods to address customer requests
- Support GC/MS and LC/MS studies including safe operation of instruments, appropriate sample preparation, applying existing lab methods, troubleshooting problems, investigations, repair and maintenance
Benefits
- Medical, dental, vision
- Life, disability insurance
- 401(k) with company match
- Generous vacation / sick time (PTO)
- Tuition reimbursement
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