JOB SUMMARY:
Client is seeking a Research Associate to join their Analytical Services team within the Development department at their contract Active Pharmaceutical Ingredient (API) manufacturing facility specializing in oligonucleotide chemistries. This role is fully onsite in Boulder, Colorado. The Research Associate will be responsible for executing analytical techniques for sample analyses to support process development studies and API manufacturing.
Key Responsibilities:
Design and conduct laboratory-scale experiments using analytical instrumentation such as HPLC/UPLC, HPLC-MS, ICP-MS, IC, GC, GC-MS, UV, and Karl Fischer
Perform analyses with adherence to ICH guidelines and internal SOPs
Safely conduct laboratory experiments using best practices for API testing
Accurately record and summarize experiments in notebooks and reports, and construct analysis summaries to present to internal and external teams
Maintain process compliance integrity by adhering to SOPs and cGMP guidelines as appropriate
Operate laboratory equipment, troubleshoot instrumentation/method issues, and perform routine preventative maintenance
Required Qualifications:
Bachelor's Degree or equivalent in Chemistry, Biochemistry, or related field
3+ years of relevant experience and/or training; or an equivalent combination of education and experience
Experience in following SOPs and methods for analytical techniques such as HPLC/UPLC, HPLC-MS, ICP-MS, IC, GC, GC-MS, UV, and Karl Fischer
Knowledge of analytical test methods used in testing of oligonucleotide API or related molecules
Strong ability to work with interdisciplinary project teams and follow project timelines
Strong organizational and documentation skills
Preferred Qualifications:
Experience with oligonucleotide chemistries and API manufacturing environments
Familiarity with cGMP compliance practices
Education:
Bachelor's Degree in Chemistry, Biochemistry, or related field
Experience:
3+ years relevant experience in analytical services, process development, or API manufacturing