QA Specialist, CTCM
Clinical Development | Emeryville, CA | Full Time
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 strong pipelines 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. For more information about Eureka Therapeutics, please visit: www.eurekatherapeutics.com.
Responsibilities include, but are not limited to:
- Hands-on execution approach to all the aspect of quality assurance within the Clinical T cell Manufacturing (CTCM). Carries out or leads monitoring efforts and populates dashboard and key indicators
- Develops, supports, and implements quality improvement initiatives; develops approaches to linking quality improvement to outcomes and reports the results
- Works with manufacturing team to develop or improve quality efforts
- Reviews documentation and assesses effectiveness of documentation review approaches; performs cause analyses and develops solutions as needed
- Gathers data and/or develops research and data analysis projects
- Actively participates in evaluation and qualification of potential contract manufacturing sites to expand the Company’s manufacturing capabilities.
- Develops and carries out complex audits (including CMO/CRO/raw material vendors) requiring content and operational knowledge of activity being audited
- Perform audits, when indicated, to ensure compliance with standards, regulations, procedures, policies, IND/IDE and clinical trials.
- Perform trending and analysis of data using appropriate quality and statistical tools. Assist in reporting data within and external to the department, institution, across institutions, and to government agencies
- Assist with or develop training documentation, review/audit competency assessments and training documentation to ensure that employee records correspond with employees’ designated tasks
- Maintains employee records of training and credentialing as required by associated regulatory standards and unit activity assigned
- Assist with correction and preventative action plans (CAPA) as needed, based on audit findings, deviations and events. Plan follow-up audits to assess if the desired effect / change was achieved
- Actively support facility & lab start-up activities and operation. Work with manufacturing teams for initial operation, and to support facility/utility/process commissioning and qualification
- Prepare, approve and manage standard operating procedures, batch records and other process documentation, including the support of product batch release
- Prepares the quality sections of manufacturing reports and modules and other documents for regulatory filings
- Other duties as assigned
Requirements and Experience:
- BS/MS in Biological Sciences, Bioengineering, Chemistry or a related discipline
- Minimum of 6 years of experience in industrial setting, including working and/or auditing batch records for process conformance, SOP, technical memo in facility
- 3+ years of industry experience with a primary focus on cell therapy manufacturing is preferred
- Working knowledge of quality systems and FDA regulatory requirements and in-depth knowledge of cGMP, SOPs and quality control processes with prior experience on supporting OOS’s and investigations
- Demonstrated ability to perform the activities described above
- Strong verbal and written communication and presentation skills
- Fluency with MS Office suite (Word/Excel/PowerPoint)
- Ability to work in a very dynamic environment of scientifically-driven biotech, with limited resources and able to plan and execute simultaneously, as well as ability to evaluate and resolve complex problems.
- For the best fit, you should be a results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues.
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.