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Manufacturing Operator

Clinical T-Cell Manufacturing (CTCM) | Sacramento, CA | Full Time

Job Description

About Us:

Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR-mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built a strong pipeline of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. To learn more about us, please visit our website at www.eurekatherapeutics.com.

Job Description:

Do you want to help cure cancer?

The Manufacturing Operator works in the newly built Clinical T-Cell Manufacturing (CTCM) group as part of the Clinical Development team. They will support lentivirus vector and/or T cell product manufacturing and engineer runs while implementing high-quality standard of execution and documentation appropriate for a GMP facility. He/she must be flexible in hours based upon business needs.

Responsibilities:

  • Manufacture lentivirus vector and/or T cell products
  • Ensure stock levels are maintained
  • Ensure machines are operational, calibrated, and/or certified
  • Perform environmental monitoring
  • Perform cleaning activities in support of line clearance
  • Perform routine product sampling as well as non-routine sampling, as needed
  • Complete and review batch records and logbooks in accordance with cGMP standards and written procedure
  • Complete training and follow appropriate gowning requirements for controlled and/or classified work areas
  • Ensure all tasks are performed in a manner consistent with cGMP SOPs and safety standards
  • Ensure process areas are stocked with crucial materials, equipment, and components
  • Reconcile components and products according to SOP and Batch Record requirements
  • Troubleshoot equipment/system failure
  • Capture and process data to support investigations associated with cell culture, purification, filling, or packaging activities
  • Provide support for the operation of, and may independently operate, a mix of manual and brand-new automated equipment such as washers, autoclaves, filling equipment, labelers, cartoners, syringe, and device assembly machines according to applicable procedures based on training and operator level
  • Maintain and ensure accurate documentation of all training
  • Assist with training of new employees, as advised
  • Other duties as assigned.

Minimum Qualifications:

  • Associate degree or equivalent experience; Bachelor’s or Master’s degree in a related science or engineering field preferred
  • Experience in a large-scale manufacturing cGMP regulated environment working with Standard Operating Procedures and cGMP documentation practices is a plus
  • Knowledge of cGMP manufacturing environment and familiarity with cGMP filling, assembly, or packaging processes preferred
  • Experience with aseptic technique and operating filling equipment or with assembly or packaging of parenteral products in vials, syringes, and cartridges using both manual and automated equipment preferred
  • Preference will be given to candidates with plasma fractionation or purification experience
  • Good verbal and written communication skills
  • Ability to grasp mechanical, fluid flow, and process parameter control concepts
  • Good math skills with knowledge of the metric system
  • Mechanical aptitude and experience with CIP systems desired
  • Must be able to lift/push/pull heavy equipment (>40lbs)
  • Strong computer skills with a basic understanding of Microsoft Office Suite (e.g. Word, Excel, and PowerPoint)
  • Experience with inventory tracking systems is a plus

 For the best fit, the candidate should:

  • Demonstrate strong interpersonal and cross-cultural communications skills
  • Exhibit confidence and strong problem-solving skills and demonstrate ingenuity, creativity, and resourcefulness
  • Gain understanding from provided instructions and work towards established goals
  • Understand and listen to team members and partners’ needs while supporting a positive team environment
  • Support the development and maintenance of a diverse and inclusive environment
  • 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.

COVID-19 Safety:

Eureka Therapeutics is committed to providing and maintaining a workplace that is free of known hazards, and to safeguarding the health of our employees and their families, visitors, business partners, and the community from the hazard of COVID-19. Vaccination is a vital tool to reduce the presence and severity of COVID-19 cases in the workplace. We highly recommend that all employees whose job responsibilities require them to work in our GMP manufacturing facility be fully vaccinated.

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.