Senior Specialist, Small Molecule Analytical Research and Development - Onsite

Accountability, Adaptability, Analytical Chemistry, Clinical Research Organizations (CRO) Management, Data Analysis, Data Review, Experimentation, GMP Compliance, Lab Equipment Maintenance, OOS Investigations, Raw Material Testing, Regulatory Compliance, Release Testing, Scientific Research, Specification Documents, Statistical Analysis, Strategic Planning, Teamwork, Technical Writing, Testing Methodology, U.S.

Though not required, the ideal applicant would have hands-on experience in GMP operations, excipient or package component release testing, spectroscopy analysis, and other analytical techniques.  In addition, experience with electronic notebooks and SAP QN are also a plus.

Small Molecule Analytical Research and Development (SMAR&D) team has an opening for a Senior Specialist in our SMARD GxP Operations team based in Rahway, NJ.

The primary objective of the SMAR&D GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical suppliesIn your role as Senior Specialist, you will be part of a cross-functional team providing analytical support towards release of raw materials and package components.  We are seeking a hands-on, lab-based scientist to support GMP testing and document creation.

The role will work collaboratively with colleagues in Pharmaceutical Operations and Global Development Quality to ensure timely release of raw materials and package components to enable advancement of our Company's research portfolio.

Conduct excipient and package component release testing for our Research & Development Division according to cGMPs.

Interface with contract laboratories to ensure timely execution of outsourced GMP testing.

Perform data review of laboratory notebooks and analytical reports.