Scientist, Analytical Operations

Arbeitsbeschreibung

Attributes Sciences is seeking a highly motivated Research Scientist with a strong expertise in viral vector characterization to support the development of Kite’s cell therapy products. In this role, the ideal candidate will be responsible for independently designing, planning and executing studies to enhance our understanding of vector quality attributes. The successful candidate will work cross-functionally to identify opportunities for continuous process improvement for viral vector manufacturing and non-viral gene editing modalities. The scope of this role will evolve and expand over time to include mentoring junior team members and partnering with key stakeholders to identify new technologies and drive continuous process & product improvement.

Responsibilities include (but are not limited to):

• Design and execute analytical studies to enhance our understanding of viral vector with a focus on identity, purity, potency, and genome integrity.

• Develop and optimize cell-based, molecular, and immunoassay methods (e.g., transduction assays, ddPCR, ELISA, flow cytometry) to assess critical vector attributes.

• Lead or support comparability and process impact studies to evaluate vector quality following manufacturing changes, scale-up, or technology transfer.

• Serve as scientific lead on analytical development initiatives related to viral vector characterization.

• Identify and evaluate emerging technologies for enhanced understanding of vector quality attributes (e.g., integration profiling, advanced flow cytometry, sequencing platforms).

• Play a key role in cross-functional intiatives aimed at assessing impact of manufacturing or process changes on vector quality.

• Engage with external collaborators and vendors to evaluate or implement new analytical platforms.

• Function as a key contributor to Analytical Development knowledge by remaining up to date on scientific literature and the newest developments in relevant fields.

• Author and review protocols, technical reports, and regulatory documentation.

• Function independently in non-routine development activities and project goals.

• Maintain accurate documentation of experiments in ELN and reports.

• Present findings at internal meetings and/or contribute to the preparation of filling and patent applications.

• Provide technical guidance and mentorship to junior staff regarding concepts of virology, immunology and cell biology.

Basic Qualifications:

• Ph.D/PharmD with 0-2+ years of postdoctoral or industry experience; OR

• MA/MS/MBA with 6+ years of relevant industry experience; OR

• BA/BS with 8+ years of relevant industry experience; OR

Preferred Qualifications:

• Strong background in virology, molecular biology, or gene therapy with experience characterizing lentiviral or retroviral vectors.

• Hands-on expertise in flow cytometry, ddPCR, ELISA, and related analytical techniques.

• Familiarity with vector quality attributes (e.g., genome integrity, vector titer and potency, vector process related impurities) and regulatory expectations.

• Prior experience with comparability strategies or process impact assessments is a plus.

• Proficiency in data analysis software (e.g., FlowJo, JMP, Prism, Microsoft office).

• Highly collaborative with excellent interpersonal, verbal and written communication skills.

• Evidence of high level of scientific expertise demonstrated through scientific publications, literature review and scientific conference participation is preferred.

• Self-motivated, organized and detail-oriented, with demonstrated ability to work efficiently as part of a team.

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

• Comfortable in a dynamic, fast-paced environment with minimal direction.

• Agile mindset and ability to adjust workload based upon changing priorities.