Job SummaryThis role will be responsible for performing analytical testing per cGMP in support of Bora raw material, in-process, final product, stability, and method transfer testing. This position will support our 3rd-shift Operations, working 10pm-6:30am, Monday - Friday. Eligible for shift differential.
Essential FunctionsReasonable accommodations will be provided to enable individuals with disabilities to perform the essential functions.- Perform various analytical testing procedures as per manufacturing/Quality Control batch records, Stability Protocols, etc.
- Execute complex methods requiring difficult sample preparation or data analysis.
- Assist with the design of method validations and execute validation studies, including method transfer activities.
- Work with Project Managers and QA to ensure timely testing and release of samples.
- Perform instrumental analysis such as Karl Fischer, UV, HPLC, and Gas Chromatography.
- Inform supervisor upon observing out-of-specification (OOS) results.
- Participate in investigations of OOS results and other related studies.
- Participate in calibration and troubleshooting of various types of equipment, including proactive resolution of instrument issues.
- Write protocols and reports as necessary.
- Plan and execute experimental tasks and obtain and interpret experimental data with minimal guidance.
- Perform review of calculations, logbooks, and other data to execute LIMS approval, lot release protocols, and final product data authorizations or approvals.
- Write and review SOPs and Testing Standards as necessary.
- Interact with clients as necessary regarding cGMP, tech transfer methods, or stability issues.
- Assist in training other Analysts.
- Review, analyze, interpret, and report data.
- Verify and enter approved results in LIMS.
- Practice good documentation and laboratory safety procedures per Standard Operating Procedures.
- Support department compliance and productivity goals.
- Track time worked per project.
- Training and education may be conducted using virtual reality/artificial intelligence.
- Participate in meetings as required.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
Minimum Education, Experience and Skills- B.S. in Chemistry, Biochemistry or other Technical Science field required with minimum of 3-5 years in a cGMP laboratory required or master's degree with 2 years of laboratory experience required.
- Demonstrated knowledge of wet chemistry, titration, UV and chromatography.
- GLP/GMP experience required.
- HPLC/GC/IC Chromatography experience is required.
- Knowledge of new and existing testing applications.
Salary Range: 88,000 - 115,000
Compensation and BenefitsWe offer a comprehensive benefits package designed to support our employees' wellbeing, including:
- Competitive salary and performance-based incentives
- Comprehensive health coverage including medical, dental, and vision insurance
- Retirement savings plans with employer matching contributions
- Paid time off
- Professional development opportunities
- Employee wellness programs and resources
- Employee Assistance Program and Mental Health Resources
