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 accurately recorded and reviewed.
• Basic maintenance of analytical equipment, including troubleshooting and upkeep.
• Method development, chemical characterization, and identification of unknowns from review of chromatographic data and libraries

Competencies of this position

• Advanced technical knowledge of UPLC, HPLC, LC-MS/MS, ICP-MS, AA techniques
• Understanding of Pharma cGMPs and ICH stability guidelines
• Good communication skills – written and verbal.
• Ability to consult with clients on projects with both technical and business level discussions
• Project management skills working concurrently on multiple projects at various stages
• Problem solving laboratory processes, method development and customer issues
• Scientific leadership and mentorship skills including data interpretation
• Must be able to work cross functionally.
• Must be able to multi-task and be self-motivated.
• Technical knowledge in areas of analytical chemistry and pharmaceutical sciences

Work Environment: 

This job operates in a professional laboratory environment. This role routinely uses standard office equipment and lab equipment including but not limited to computers keyboards, computer mouse, telephones, photocopiers, file cabinets, microscopes, micropipettes, pipette aids, various hand tools and analytical equipment. Possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds and other environmental aspects which may be considered unfavorable. Employees are expected to follow Biosafety and Chemical Hygiene policies, practices, and procedures.

Education and experience requirements:

• Analytical instrumentation experience required – UPLC, HPLC, LC-MS, ICP-MS, AA
• PhD Chemistry or Material Science with 7+ years in analytical chemistry, biophysics, biochemistry, or related fields, with an emphasis on liquid chromatography and mass spectrometry strongly preferred.
• MS Chemistry with 10+ years in analytical chemistry, biophysics, biochemistry, or related fields, with an emphasis on liquid chromatograph and mass spectrometry strongly preferred.

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies. 

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com. 

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,800 customers across 14 facilities in the United States, Mexico, Asia and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues. Learn more about Nelson Labs at www.nelsonlabs.com 

Safeguarding Global Health® – with every test we complete.

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