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Manager/Associate Director, Quality Assurance, CTCM

2 months ago

Sacramento, United States Eureka Therapeutics Full time

Job Description

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 Manager, Associate Director, Quality Assurance is to work as part of the Clinical T-Cell Manufacturing (CTCM) - Product Development team, reporting to the Head of Quality. As an active member of the CTCM team, he/she will provide key support to our clinical LVV and T-cell manufacturing programs. Responsibilities include supporting, establishing, and developing quality systems in the manufacturing/QC functional areas, providing training, conducting EM activities, performing internal and supplier audits, conducting batch review and release and working with Clinical operations to coordinate in-process and final product labeling requirements. Eureka is a high growth, fast paced, small organization.

Responsibilities include, but are not limited to:

  • Provide GMP guidance to manufacturing team on the floor.
  • Conduct batch review and release.
  • Review and release in-process and product labeling.
  • Support building up and implementing quality systems to support ongoing phase I/II cell therapy clinical trials.
  • Review and approve QCTRs, Certificate of Testing, Certificates of Analysis, technical protocols and reports for clinical manufacturing process development, and QC assay qualification/validation.
  • Identify and handle deviations and out-of-specification (OOS) results within CTCM; initiate CAPA processes and investigate the root cause and ensure timely closure of CAPA; ensure all deviation, OOS result, and CAPA records are accurate, complete, and auditable; and compile and analyze the deviation, OOS, and CAPA data for future improvement.
  • Proactively communicate with the process development, QC, and clinical operations team members to resolve defects in the quality systems and prevent future occurrences.
  • Ensure new vendors (including CMOs and CROs) that provide products and/or services to support the clinical trials have been qualified and approved.
  • Support audits/inspections from regulatory agencies or third parties.
  • Assist in inventory inspections, inventory counts, and receiving inspections.
  • Manage and participate in environmental monitoring testing.
  • Train operators on GMP documents as needed.
  • Ensure that personnel are trained in manufacturing processes before performing.
  • Ensure equipment is being managed appropriately.
  • Share the office responsibility of answering incoming calls, performing receiving of deliveries, and guests.
  • Conduct internal and supplier audits.
  • Other duties as assigned.
Minimum Qualifications:
  • B.S./B.A. degree in a scientific field required; advanced degree is a plus.
  • BS degree, or equivalent, in a pharmaceutical-related field with a minimum of 8 years of experience in Quality and/or manufacturing support, including at least 5 years of supervisory experience.
  • Comprehensive knowledge of current Good Manufacturing Practices and the ability to correctly interpret phase appropriate GMP standards.
  • Batch review and release experience.
  • Solid internal and external auditing experience.
  • Experience with Quality Systems (e.g. deviations, investigations, and CAPA programs).
  • Experience in handling FDA inspections.
  • Strong verbal and written communication skills are required.
  • Proven ability to interpret regulations, to define and communicate strategy plans.
  • Ability to work in a dynamic environment of a scientifically driven biotech with limited resources.

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.