Process Engineer II, Process Development

4 weeks ago


Santa Monica, California, United States Neogene Therapeutics Full time

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

Neogene is seeking a motivated Process Engineer II with expertise in cell therapy to join our Process Development team. This laboratory-based role will support development of a clinical manufacturing process of engineered T cells with patient-derived neo-antigen specific TCRs. The process engineer will be responsible for evaluation of technology and process improvements and play a key role in process understanding and process characterization. The successful candidate will have knowledge of basic engineering principles, bioprocess development, and cGMP manufacturing. This role is based in Santa Monica, CA and reports to the Sr Scientist, Process Development.

Essential Functions and Responsibilities

Design, execution, analysis, and documentation of early and late stage process development studies to develop, optimize, characterize and transfer cGMP manufacturing processes. Involves cell culture of T cells in multiple formats including flasks, bags, and bioreactors.
Collaborates within the team to interpret study results and contribute to technical discussions cross functionally for subsequent study design and decision making.
Prepare experimental proposals, technical reports and presentations, SOP and manufacturing records.
Perform other duties and special projects as assigned.

Supervisory Responsibilities
No supervisory responsibilities.

Required Skills/Abilities
Experience in technical development of cell and gene therapy or biologics in early and late stage development
Hands-on experience in cell and gene therapy, specifically in T cells is highly desirable.
Knowledge of cGMP manufacturing and regulations and practical experience in GMP
Knowledge of QbD, DOE and statistical analysis tools (e.g. JMP, MiniTab).
Ability to think critically, analytically and have demonstrated troubleshooting and problem- solving skills based on deductive
Strong verbal and written communication skills, including technical writing.

Education and Experience
MS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology or related field with 2+ years relevant industry experience or BS degree with 4+ years relevant industry

The anticipated salary range for candidates who will work in Santa Monica, CA is $70,000 to $82,000. 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.

DE&I Statement

Headline: We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
A collaborative culture that leverages the diverse perspectives of employees and supports courage
Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."


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