Analytical Development

3 weeks ago


St Francis, United States Kingchem Full time

Kingchem Laboratories Inc. is a full GMP CDMO facility for the manufacture of GMP intermediates, APIs, and excipients located in St. Francis, Wisconsin (USA).

 

The Position

This position is in the Analytical Development & Validation (ADV) within the Quality group of a CDMO. An Analytical Development Scientist I will support method development/validation, metrology activities for new drug substances (API), and support IQ OQ/PQ of analytical instruments. This position reports to the QC Manager with dotted line report to Director of Quality & Regulatory Affairs.

 

Responsibilities

* Work closely with R&D scientists and analytical groups to provide accurate analytical results in support of new and on-going projects.

*Work with supervision to meet project timelines and deliverables.

*Design and initiate development of analytical methods and improvement of existing ones, to support all stages of API (active pharmaceutical ingredient).

* Perform validation, and method transfer activities for APls.

* Evaluate and interpret scientific data and provide the significance of such with supervision.

* Assist in the design and execution of non-routine experiments with supervision.

* Analyze data/results and interpret outcome of experiments and propose appropriate follow-up with supervision.

* Write project documentation (Analytical test methods, developmental reports, and protocols) of medium complexity.

* Embrace cGMP requirements for all work associated.

* Perform maintenance, Calibration (IQ, OQ&PQ) and troubleshooting of analytical Instruments.

* Other duties as assigned.

 

Requirements

* B.S. in Chemistry (or related field) with 7-10 years of relevant Analytical Development and Validation experience in a GMP & GDP manufacturing environment.

* Experience In Technical writing is a plus.

* Experience in Analytical Instrument Metrology is a plus.

* Proficiency with some related analytical techniques, such as HPLC, GC, FTIR, UV/Vis, LC/MS, KF, GC/MS, NMR and XRD etc. Willingness to learn new techniques.

* Familiar with analytical instrumentation, test methodology/validations of USP and EP, data acquisition systems, and cGMP policies and practices.

* Skills and knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals, and related organic molecules.

* Understanding of basic theories and principles of synthetic organic chemistry.

* Works well with others in a team environment.

* Sharp attention to detail.

* Can perform tasks assigned with minimal supervision.



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