Sr. Analytical Chemist – Pharmaceutical (Chemist III)

A Senior Analytical Chemist in our pharmaceutical services business will implement analytical techniques to characterize complex pharmaceutical products, primary and secondary containers as well as develop methods for the assessment of raw materials, APIs and finished pharmaceutical products in a contract laboratory setting.

This role may work across a variety of industries, including pharmaceuticals, biotechnology, and specialty gases.

Requires a strong understanding of analytical techniques and equipment including liquid and gas chromatography for analyses (UPLC, HPLC, LC-MS, GC-MS), elemental analysis (ICP-MS, AA), activity measurement, and impurity measurements.

Must have strong problem-solving skills, effective communication skills, and the ability to mentor and train other chemists.

Understanding of and compliance to cGMPs, cGXPs and GDPs is a must in the lab operation.

Primarily this role will develop protocols and execute tests for pharmaceutical product method feasibility, development, verification and validation in collaboration with clients related to APIs and finished product.

The ability to analyze complex data and interpret the results of experiments is crucial and may include performing literature searches and extracting information from journals and protocols to develop, improve, and validate analytical methods that are compliant with GMPs.

Oversight of scientists, managing lab supplies and equipment, and resolving technical issues may be required along with training on analytical techniques and procedures.

Senior Analytical Chemists may also perform routine maintenance and troubleshooting on analytical equipment, participate in method transfer activities, and provide updates to customers along with consultants.

Participation in industry standard committees and working groups with presentation opportunities at industry events, trade shows, company sponsored seminars, and at client facilities may be requested.

Essential Duties:

Scientific/General


* Performance of studies according to approved procedures and cGMPs, ICH guidelines


* Execution of studies utilizing UPLC, HPLC, LC-MS/MS, ICP-MS, AA techniques


* Oversight of pharmaceutical stability studies following ICH guidelines


* Competency in data analysis software such as LabX, OpenLab, or similar systems


* Prepare and review written procedures including SOPs, STPs, and other protocol test procedures and instructions that will be followed during analysis.


* Ensure procedures and reports are current with published methods.


* Ensure final reports accurately reflect the data, results, and conclusions of the testing.


* Evaluates test results for suitability and designates acceptability.


* Ensure proper safety measures are taken in the lab.


* Ensure sample and data traceability are maintained throughout testing.


* Ensure calculations and statistics accurately reflect the raw data.


* Ensure test controls and monitors are a...