What are the responsibilities and job description for the Analytical Chemist II 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 both supervisory and technical experience. Develop new methodology and novel approaches to problem solving for analysis of trace constituents in testing matrices (aqueous & solid). Responsible for method transfer in a coherent manner to subordinate chemists while adhering to appropriate regulatory requirements, including SOP’s, Protocols, US FDA and US EPA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP). Analytical Chemist II will typically report to the LC group or the GC group, but may have experience in multiple types of chromatography.
This position is fully on site at our Canton, MA location.
Critical Performance Areas
- Develop new methodology for analysis of trace constituents in testing matrices using HPLC/MS, DI-GC/MS, HS-GC/MS, and/or HRAMS chromatographic techniques.
- Accurately record and document raw data, observations and pharmacy usage.
- Ensure that work conforms to appropriate regulatory requirements, including SOP’s, Protocols, US FDA and US EPA Good Laboratory Practices (GLP), US FDA current Good Manufacturing Practices (cGMP), ICH and USP guidance.
Essential Job Functions
- Broad knowledge of analytical chemistry and regulatory compliance pertinent to the work being completed.
- Preparation of analysis of samples in a variety of matrices, using chromatographic and spectroscopic/spectrometric methods.
- Responsible for overall direction of studies, including keeping management informed of study performance, and timelines.
- Properly execute instrument validation and method development procedures.
- 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.
- Accurate and timely completion of employee timesheets.
Requirements
- AS/BA/BS degree in a scientific area of study (chemistry is preferable). Master's or higher degree is preferred.
- Minimum of 2 years of experience.
Other Desired Skills/Abilities
- Experience in a CRO/CDMO is preferred.
- Experience in a GMP or GLP environment
- Familiarity with an electronic quality management system (e.g. MasterControl) is highly recommended.
- Ability to work in a team environment where timely delivery is essential and shifting priorities can be expected.
- Demonstrate familiarity with Microsoft products such as Word, Excel, PowerPoint, Outlook, Access, and Teams.
- Strong written and verbal communication skills and attention to detail.
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.
Salary : $70,000 - $90,000