Kelly® Science & Clinical is seeking a Senior Analytical Chemist opportunity with one of our clients, a leading small molecule CDMO at their Irvine, CA facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Workplace: Onsite in Irvine, CA.
Salary: $90,000-$100-000
Responsibilities
- Understand and run HPLC, GC, ICP, UV, FTIR, Dissolution tester, and other analytical instrumentation in an analytical lab setup.
- Work on MS Word, Excel, and any one of the chromatography data collection and management software such as Empower, and ChemStation.
- Perform analytical testing of raw materials, in-process samples, and finished products.
- Maintain and troubleshoot analytical instrumentation.
- Validate/verify new and existing USP methods, and establish a documentation system for drafting, reviewing, and approving method validation protocols, reports, and analytical method SOPs.
- Support analytical methods and method development for pharmaceuticals (solids, semisolids, and liquid dosages) and enhance the strength and purity confirmation of our products.
- Conduct method improvements and modifications on commercial analytical methods for pharmaceuticals.
- Conduct method development and USP method feasibility studies for assay, trace elements, and associated characteristics for pharmaceuticals.
- Troubleshoot problems associated with analytical methods for pharmaceuticals including raw materials, finished product method development, quantitative and qualitative analysis, and improvement of analytical methodologies.
- Work with the Lab Manager to develop and build a system for pharmaceutical analytical methods by establishing documentation protocols, including drafting, reviewing, and approving method validation protocols, reports, and analytical method SOPs.
- Analyze organic and inorganic compounds to determine chemical and physical properties.
- Coordinate with our Quality Control department to smoothly transfer validated methods to QC chemists.
- Assist laboratory management in preparation for internal, customer, and agency audits.
Qualifications
- BS, MS, or PhD in Chemistry, biochemistry, or related degree:
- 8 years of small molecule drug discovery experience
- Experience with analytical instrumentation, such as HPLC, GC, CE, ICP, FTIR, and dissolution apparatus in a GMP environment.
- Working knowledge of MS Word, Excel, and any one of the chromatography data collection and management software such as Empower, ChemStation, etc.
- Understand and apply cGMP principles and FDA regulations for pharmaceuticals.
- Must be a self-starter, work under limited supervision, and be capable of taking initiative in prioritization and implementation of work.
- Able to read and interpret scientific articles and documents, such as method development publications, FDA regulations, safety rules, and procedure manuals.
- Mastery in calculations and the recording of results of testing in lab books and laboratory reports according to SOPs and cGMP principles.
- Strong team player; able to build rapport and work with other departments.
- Able to communicate professionally and concisely at all levels of the organization.
What happens next:
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.