POSITION SUMMARY
Umoja's Analytical Development organization is seeking a driven Associate Scientist II for the Process Analytics department to deliver routine UPLC analytical methods. This person will transfer or develop separation methods to quantify residual process reagents in lentiviral vector (VivoVec) Drug Product and in-process samples. In addition, new method development utilizing separation techniques to enable product quality understanding is required. Early phase validation and transfer of these methods to Quality Control is critical to enable release testing of GMP lots.
The ideal candidate is experienced in chromatography systems and multiple detection methods. The successful candidate will be independent and will be responsible for meeting timelines. This role will also require attention to detail and proper documentation of execution of experiments in an Electronic Laboratory Notebook (ELN), as well as contributing to report writing. This position works closely with other functions to aid in development and successful transfer of qualified methods to QC Analytical.
This role is fully onsite 5 days/week and almost entirely lab based at our Louisville, CO location.
CORE ACCOUNTABILITIES
• Develop and execute UPLC methods to quantify process reagents to demonstrate effective clearance • Collaborate with AD and QC team members on various stages of analytical method lifecycle (development/qualification/transfer) • Collaborate with systems engineer to create sample submission and result reporting workflow to support ongoing testing • Maintain clear records of experimental work using an electronic notebook system that adheres to company guidelines • Manage and prioritize sample submissions for respective method(s) and report data in timely manner • Prepare technical data reports and presentations • Contribute to other analytical method(s) development and testing as necessary • Exemplify the company core values and adhere to company policies to ensure safety and quality of gene therapy products and facility
REQUIREMENTS
The successful candidate will have:
• S. in Biology, Biochemistry, or related discipline with a minimum of 7+ years of experience, equivalent combinations of education and experience will be considered • Expertise with UPLC systems, Thermo (Chromeleon) preferred • Excellent communication skills with the proven ability to build open and collaborative relationships and successfully work as a member of a multidisciplinary team • Preferred Qualifications: • Expertise with nano and UPLC • Experience with UV/VIS, Fluorescence, CAD, quadrupole MS, ICP-MS detection • Experience with viral vectors (e.g., AAV, LVV) and/or additional analytical methods (dPCR, qPCR, ELISA, etc.) a plus • Self-motivated and organized • Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects • 100% compliance with personal protective equipment (PPE) requirements in laboratory environments, including gloves, protective clothing, and eye safety glasses • Ability to perform physical tasks required for the role, including standing, walking, bending, kneeling, sitting, working your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds • Ability to work onsite 5 days/week at our Louisville, CO location
SALARY RANGE The salary range for this position is $108,600 - $134,200.