What are the responsibilities and job description for the Analytical Chemist III position at Solvias?
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Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards.
Position Overview
Requires supervisory and/or technical experience. Responsible for overall direction and completion of analytical studies. Develop new methodology and novel approaches to problem solving for analysis of trace constituents in test materials for pharmaceutical applications. Responsible for method transfer in a coherent manner while adhering to appropriate regulatory requirements, including SOP’s, Protocols, US FDA Good Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP).
Critical Performance Areas
- Develop new methodology for analysis of drug substance and drug products in support of Contract Analytical Programs.
- Responsible for overall direction and completion of studies.
- Accurately record and document raw data, observations and pharmacy usage.
- Ensure that work conforms to appropriate regulatory requirements, including SOP’s, Protocols, US FDA Good Laboratory Practices (GLP), US FDA current Good Manufacturing Practices (cGMP), ICH and USP guidance.
Essential Job Functions
- Advanced knowledge of analytical chemistry and regulatory compliance pertinent to the work being completed.
- Preparation for analysis of samples, in a variety of matrices, using chromatographic and spectroscopic/spectrometric techniques.
- Responsible for overall direction and completion of studies, including making key recommendations to management regarding study performance and timelines.
- Properly execute method development and validation per ICH/USP guidelines.
- Effectively interact with management, senior staff members, co-workers and external contacts.
- Strict adherence to Lab Safety Guidelines and demonstrate chemical safety, proper chemical use, chemical labeling, storage and housekeeping.
- Accurately project staff and additional resource needs to management in a timely and effective manner.
- Assist in training new chemists in acceptable laboratory and regulatory practices.
- Accurate and timely completion of employee timesheets.
Requirements
- MS or Ph.D. in Chemistry is preferable, BA/BS degree in related science (advanced degree in Chemistry is preferable) and 5 years of experience with 2 years cGMP experience minimum.
Other Desired Skills/Abilities
- Ability to work in a team environment where timely delivery is essential.
- Strong written and verbal communication skills.
Reporting Structure
This job typically reports to:
- Manager, Senior Manager, and/or Director, Analytical Services.
NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.
Disclaimer: Solvias USA, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.