The position is on-site and lab-based, requiring relevant expertise in vibrational (FTIR and/or Raman) spectroscopy and compendial analytical techniques to support release testing of raw materials, excipients, intermediates, and starting materials used in the manufacturing of clinical drug substances and drug products. This position is located at New Brunswick, NJ (NBR) site, reporting directly to a Principal Scientist within the GxP Biologics and Pharma Raw Materials Group of the Analytical Strategy & Operations (ASO) department.
DUTIES & RESPONSIBILITIES:
Essential Duties and Responsibilities include, but are not limited to, the following:
- Independently perform analytical testing including but not limited to FTIR and Raman spectroscopy methods, color & physical appearance tests, pH and osmolality measurements, compendial wet chemistry identification methods (e.g., USP), and other general analytical lab techniques. Executed tests will support clinical release and stability testing of drug substances, drug products, excipients and raw materials used in the manufacturing and formulation of Clinical drug substances and drug products.
- Demonstrate practical knowledge of analytical techniques contributing to the development of phase-appropriate robust and reproducible analytical methods used in a GMP testing laboratory.
- Maintain clear, complete, accurate and GMP-compliant documentation for experiments.
- Independently execute analytical method qualifications, verifications, and validations (as applicable), carefully adhering to approved protocols.
- Contribute to study design and the authoring of analytical protocols and reports.
- Proactively provide clear, timely communication of potential issues to management.
- Organize and present data for internal meetings.
- Proactively provide clear, timely communication of potential issues to management.
Professional Qualifications:
- The candidate must have a B.S. or equivalent with a degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent; 1-2 years of analytical laboratory experience in a GMP environment is strongly preferred.
- An understanding of cGMP/GLP and GDPs practices and EHS requirements is essential for success in this position. Ability to comply with all applicable SOPs, internal and external (ICH, compendial) requirements/regulations is a must.
- The candidate must be able to deliver when working under assigned timelines and demonstrate good communication skills, particularly in documentation of data and writing reports and methods. Skill in communicating/escalating critical issues to appropriate team leaders and functional area management is necessary.
- Expertise in MS Office applications, in particular MS Word and Excel, is required. Familiarity with electronic documentation systems (e.g., Qumas, Infinity, Syncade-DCA) for routing protocols/reports, investigation reports for review and approval is a plus.
- Experience in use of scientific reporting applications and ELN software, e.g., VelQuest, Symyx and LIMS is preferred.