Principal Research Associate, Process Development

at  Neogene Therapeutics

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.
We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.
Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

POSITION SUMMARY

The Principal Research Associate, Process Development is responsible for supporting and contributing to the design and execution of studies to develop and further optimize clinical manufacturing processes of Neogene portfolio of engineered TCR T cell therapies. This role is based in Santa Monica, CA, and reports to the Senior Scientist, Process Development.

Essential Functions and Responsibilities

• Participate in the design, execution and support of laboratory studies for development, optimization, and manufacture of genome engineered TCR T cell products using non-viral genome editing tools.
• Execute and support analytical methods for process development studies.
• Support experimental designs, planning, execution, analysis, and reporting results of process development studies.
• Participate in a cross-functional team to transfer technology to cGMP manufacturing partners.
• Support, author, and review protocols, technical reports, regulatory documents and memos to summarize experiments and investigations.
• Collaborate with internal and external partners to evaluate and implement new process technologies to develop next generation processes.
• Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.
• Work effectively in a team environment to meet project timeline and objectives.
• Perform other duties as assigned.

REQUIRED SKILLS/ABILITIES

• Proficiency with Microsoft Excel or statistical analysis software (JMP, Minitab, Prism, etc.) for analyzing and presenting data.
• Working understanding of US/EU regulatory requirements and working knowledge of cGMPs.
• Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
• Ability to design and execute experiments with minimal technical supervision.

EDUCATION AND EXPERIENCE

• MS degree in Immunology, Cell Biology, Molecular biology, Bioengineering with 2+ years relevant experience or similar BS degree with 4+ years relevant experience within the pharmaceutical or biotech industries.
• At least 3 years of relevant experience in developing production processes for genome engineered primary cells (required) including T cells (highly preferred).
• A minimum of two (2) years practical experience with Flow Cytometry.
• Hands-on experience performing analytical methods typically used in the manufacture and characterization of biological products.
  The anticipated salary range for candidates who will work in Santa Monica, CA is $85,000 to $110,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.
  Note: At this time, Neogene is not sponsoring VISAs.
  At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

SUPERVISORY RESPONSIBILITIES

• Oversee Junior associates in execution of development activities.

Essential Functions and Responsibilities

• Participate in the design, execution and support of laboratory studies for development, optimization, and manufacture of genome engineered TCR T cell products using non-viral genome editing tools.
• Execute and support analytical methods for process development studies.
• Support experimental designs, planning, execution, analysis, and reporting results of process development studies.
• Participate in a cross-functional team to transfer technology to cGMP manufacturing partners.
• Support, author, and review protocols, technical reports, regulatory documents and memos to summarize experiments and investigations.
• Collaborate with internal and external partners to evaluate and implement new process technologies to develop next generation processes.
• Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.
• Work effectively in a team environment to meet project timeline and objectives.
• Perform other duties as assigned