Principal Analytical Scientist
West Deptford, NJ, USA | Johnson Matthey
Job Description:65 people have viewed this job
Responsible for the implementation, development and validation of analytical methods in support of process research, cGMP production, and stability testing, with particular emphasis on LC, GC, GC/MS, and LC/MS methods. The responsibility includes writing and reviewing technical documents such as method protocols, reports, supporting investigations and DMF filing.
Major functions include method optimization, transfer, and verification of compendial procedures. Other duties may involve sample analysis by a variety of analytical techniques including LC, GC, PSD, KF, titrations, and a variety of instrumental and wet chemical techniques. The incumbent may function as the primary contact on one or more chemical development projects. In-depth involvement with the project team concerning the chemistry of the project and analytical chemistry needs is expected.
Develops new analytical procedures.
Validates analytical methods.
Independently, detects and solves complex problems of high technical difficulty.
Conducts investigations independently.
Analyzes research and production samples.
Supervises, directs and reviews the work of other analytical chemists and scientists.
Documents all analyses per SOPs.
Prepares SOPs, analytical methods, validation protocol, reports and other GMP documentation.
Reviews data generated by other analysts.
Applies knowledge and expertise from multi-disciplines (including QA, QC, Analytical and production) to achieve project goals.
Maintains and repairs analytical instrumentation.
Supports qualification of reference materials.
Provides training on various analytical techniques and cGMP procedures.
Prepares and reviews scientific reports.
Interfaces with internal and external clients.
To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
Are you the ideal candidate?
PhD in Analytical Chemistry or equivalent with a minimum of 8-10 years’ experience in a GMP environment.
MS in Analytical Chemistry or equivalent with a minimum of 12 years’ experience in a GMP environment.
Minimum of 8 years’ experience in method development and validation for small molecule Active Pharmaceutical Ingredients (APIs).
Experience with Process Development of APIs.
Experience with LC, GC, GC-MS, LC-MS, IC, spectroscopy, and wet chemistry
Experience mentoring staff members in an analytical department
Experience with writing method validation protocols and reports
Knowledge of cGMP, FDA guidance, ICH guidelines, and compendial regulatory requirements
Experience with developing highly sensitive method for trace-level determination i.e. genotoxic impurity analysisdesirable
Experience with Microsoft Office and other complex computer software (Empower3) desirable.
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