Senior Engineer – Facilities and Engineering

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 Therapeutics is a pre-clinical stage biotechnology company aiming to change the paradigm of treatment for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.

We are seeking a highly motivated individual for the role of Sr. Engineer, Facilities and Engineering, to work in an exciting new area of Cell Therapy at Neogene Therapeutics. This role reports directly to the Facility and Engineering Lead in Santa Monica, CA.

The Senior Engineer, Facilities & Engineering will be responsible for completing tasks which support the day-to-day operations and deliverables to the business.

Essential Functions and Responsibilities

• Maintain fit for purpose Asset Lifecycle Management System for GMP and non-GMP assets.
• Maintain fit for purpose Calibration and Maintenance Program for non-GMP and GMP Assets.
• Coordinate site Maintenance activities and ensuring that all activities are completed by the original due date or extended if due date cannot be achieved.
• Responsible for execution of work orders by vendors and acting as a point of contact for facility maintenance services at the Santa Monica facility locations.
• Support or lead activities related to facility operation including equipment procurement, installation, and overseeing execution of commissioning and qualification of analytical and facility equipment.
• Develop equipment and system specifications, procure, install, and oversee execution of commissioning and qualification of new equipment and systems.
• Develop and revise Standard Operating Procedures (SOPs) and associated training for Facilities and Engineering department.
• Provide oversight and support for Facilities and Engineering programs to ensure compliance with necessary Environmental Health and Safety regulations.
• Provides Engineering and Maintenance support to troubleshoot and improve/maximize the performance of equipment and processes.
• Maintain documentation associated with facilities, maintenance and affected manufacturing processes.
• Complete on time project updates, development plans and self-assessments.
• Perform other duties and special projects as assigned.

Supervisory Responsibilities

• Responsible to supervise vendors/contractors in execution of required facility maintenance, site engineering or investigations as needed.

Required Skills/Abilities

• Knowledge of industry practices, cell therapy Facility and Engineering experience highly desirable.
• Proficiency with Calibration and Maintenance Management Systems (e.g. Blue Mountain, Maximo), Building Management Systems and/or Equipment Monitoring Systems preferred.
• Demonstrated ability to identify, analyze and solve problems independently, make timely decisions and know when to escalate and when to delegate.
• Clear understanding of cGMP principles, concepts, practices, and standards.
• Must have very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.

Education and Experience

• Bachelors with a minimum of seven (7)years OR a Masters with a minimum of five years of experience 
• At least 3 years of pharmaceutical or biotech industry experience in increasing levels of responsibility or Lean Facility and Engineering principles.

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.”