Front Line Manager/Plant Manager
Clinical T-Cell Manufacturing (CTCM) | Sacramento, 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 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.
The Front-Line Manager for the Pilot Plant (based in Sacramento, CA) is to lead a team of staff responsible for daily T cell or Lentiviral Vector (LVV) manufacturing and QC and QA functions. This position will work closely with the Product Development group and Quality group under Clinical T-Cell Manufacturing (CTCM) department at Headquarters (Emeryville, CA).
The FLM will play a key role in performing hands on evaluations and forming collaborations both internal to Eureka and with vendors to advance upstream and downstream processing capabilities. In addition, the GLM will perform or oversee new product introductions, technology transfer, experimental design, equipment commissioning and participate in equipment design.
- Performs processing on the floor and supporting activities such as media preparation, equipment set- up/cleaning and equipment commissioning
- Oversees production runs, QC, QA and characterization efforts
- Ensures equipment maintenance, calibration and validation
- Manages environment control
- Maintains and/or manages the inventory system
- Ensures production activities meet demand
- Manages projects; trains, supervises and mentors staff
- Ensures a premier safety culture
- Continuously implements LEAN concepts for the improvement of efficiency and productivity as well as ensuring data integrity
- Defines & documents operation practices
- Ensures documentation (lab notebooks, technical reports, BPR) accurately reflects operations performed
- Leads routine operations meetings
- Analyzes data, processes results, summarizes findings and identifies challenges to future commercial processes
- Communicates results through internal cross-functional team meetings
- Other duties as assigned
B.S., M.S. or Ph.D. in Biology, Chemistry or Chemical/Biological Engineering fields with a minimum of 8 years of manufacturing and operations experience.
Working knowledge with cGMP manufacturing and regulatory requirements for biological products.
- Solid knowledge of upstream and/or downstream, as well as a general knowledge of analytical assays.
- Previous managerial experience directly managing people and/or experience in leading teams, projects, programs or directing the allocation of resources.
- Strong skills in planning, forecasting and budgeting; minimum of 5 years of experiences preferred.
- 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.
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.