Associate Director, GMP Facility - Eureka Therapeutics

About Us:

Eureka Therapeutics, Inc. is a privately held clinical-stage biotechnology company focused on developing novel T-cell therapies to treat cancers. Its core technology centers around its proprietary ARTEMIS® cell receptor platform and E-ALPHA® antibody discovery platform for the discovery and development of potentially safer and more effective T-cell therapies for the treatment of solid tumors and hematologic malignancies. The company currently has two clinical programs, ET140203 (ARYA-1 for adults and ARYA-2 for pediatrics) and ECT204 (ARYA-3), in Phase I/II US trials in patients with advanced liver cancer.

Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information on Eureka, please visit www.eurekatherapeutics.com. ARTEMIS and E-ALPHA are registered trademarks owned by Eureka.

Job Description:

The Associate Director, GMP Facility for the Pilot Plant (based in Sacramento, CA) is responsible for maintaining and scaling the GMP facility as it continues to expand in personnel and scope. This position oversees the strategy to build out daily operations of the GMP facility such as managing all maintenance, repairs, and improvements made to the facility. This position works closely with the Product Development group and Quality group under Clinical T-Cell Manufacturing (CTCM) department in the Headquarter (Emeryville, CA).

Responsibilities:

• Oversee maintenance of the GMP facility, ensuring that they meet operational needs and comply with relevant regulations and standards.
  • Responsible for sub functions within Manufacturing Engineering and Facilities, including but not limited to maintenance, engineering, calibration, automation, equipment validation and site services.
  • Negotiate, manage, and administer all contracts relating to facility operations, including but not limited to janitorial, HVAC equipment, pest control, fire suppression, plumbing, and alarm systems.
  • Responsible for working with the University of California, Davis (UCD) facility counterparts to ensure that UCD building activities (e.g., shutdowns, generator issues, building alarms, etc.) that impact Eureka are made known and communicated to Eureka CTCM in a timely manner, so that impact is assessed and issues that arise are communicated and worked out with UCD.
  • Manage and oversee security and disaster response.
  • Collaborate with cross-functional teams to identify and address facility and equipment-related needs and improvements aligned with business objectives.
• Prepare and submit accurate and timely reports on facilities management, HSSE metrics, and key performance indicators to internal team and regulatory bodies. Lead Health, Safety, Security, and Environment (HSSE) effort.
  • Establish safety programs, protocols, and training to ensure a safe and secure working environment for employees, visitors, and contractors.
  • Conduct regular inspections, risk assessments, and audits to identify potential hazards, non-compliance issues, and areas for improvement.
    • Lead incident investigations, root cause analyses, and the implementation of corrective and preventive actions.
    • Foster a culture of safety and environmental consciousness by promoting awareness, training, and employee engagement initiatives.
    • Lead Safety Committee efforts in Sacramento to ensure OSHA, state and county safety compliance and to encourage and maintain a safe work environment.
    • Collaborate with Emeryville Safety Committee to create a safe work environment consistent across all Eureka facilities.
• Other duties as assigned

Minimum Qualifications:

• Bachelor's degree in engineering, facilities management, occupational health and safety, or a related field. Advanced degree preferred.
• Extensive experience (10+ years) in facilities management, HSSE, or related roles, preferably within the biotech or pharmaceutical industry.
• In-depth knowledge of facility operations, maintenance best practices, and regulatory requirements.
• Managerial experience in leading teams, projects, programs and allocation of resources.
• Must be able to work off hours or non-standard shifts.
• Ability to work in a dynamic environment of scientifically driven biotech and able to plan and execute simultaneously, as well as ability to evaluate and resolve complex problems.

For the best fit, the candidate should be a fast learner who is detail-oriented and results-driven with outstanding organizational skills, and a team player with strong interpersonal and communications skills and capable of working collaboratively with colleagues. The candidate should be comfortable in a fast-paced environment, able to adjust workload based upon changing priorities and willing to take additional responsibilities outside of initial job description.

To Apply:

Please submit your resume or CV and cover letter to Jobscore. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law.

If you are a recruiter or placement agency, please do not submit resumes to any employees at Eureka Therapeutics, Inc. prior to having a signed agreement. Eureka Therapeutics is not liable for and will not pay agency fees for candidates submitted by any agency other than its approved recruitment partners. Furthermore, any resumes sent to us without an agreement in place will be considered your company’s gift to Eureka Therapeutics and may be forwarded to our recruiters for their attention.