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.

The anticipated salary range for candidates who will work in Santa Monica, CA is $125,000 to $149,000. 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.

At this time, Neogene is not sponsoring VISAs.

Neogene Therapeutics requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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.