Scientist, Analytical Development

 

POSITION SUMMARY

Umoja’s Analytical Development organization is seeking a driven Scientist to deliver routine (U)HPLC as well as troubleshoot, improve and/or develop separations based analytical methods for the Process Analytics department.  This role will be responsible for managing current method lifecycle and developing new separation strategies to quantify residual process reagents, impurities in lentiviral vector (VivoVec) Drug Product and assist in product and process characterization. This position requires an exploratory and proactive approach to method development, including identifying and developing new separation methods to quantify residuals in VivoVec, raw materials, and media components to support evolving process needs, using appropriate chromatographic and detection strategies.

The ideal candidate is experienced in chromatography systems and multiple detection methods and will work independently to meet timelines. Responsibilities may include oversight and transfer of analytical assays for internal and external partners, qualification of newly developed or external methods, and successful transfer of methods to QC to enable release of GMP material. This role balances routine sample testing to support ongoing process needs with development, qualification, and transfer activities, and requires strong communication skills to collaborate with cross‑functional and external partners. Attention to detail, thorough documentation of experimental work in an Electronic Laboratory Notebook (ELN), and authorship of development and qualification reports are essential.

This role is fully onsite and lab-based 5 days/week at our Louisville, CO location.

CORE ACCOUNTABILITIES
Specific Responsibilities include:

• Develop and execute novel (U)HPLC and separation methods to characterize and quantify lentiviral products, raw materials and impurities, including 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 informatics engineers to create sample submission/result reporting workflows and integrate automation to support ongoing testing and improve efficiency.
• 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.

The successful candidate will have:

• PhD/MS/BS in Biology, Biochemistry, or related discipline with of relevant experience, respectively. Equivalent combination of education and experience will be considered.
• Expertise with (U)HPLC systems and chromatography separation analytics, Thermo (Chromeleon) preferred with multiple separation and detection methods
• Experience in novel method development and method improvement initiatives
• 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 (U)HPLC
• 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
• Experience in method qualification and Quality transfer
• Self-motivated and organized
• Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects

Physical Requirements

• 100% compliance with personal protective equipment (PPE) requirements in laboratory environments, including gloves, protective clothing, and eye safety glasses.
• 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: $122,100 - $150,800