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02.15.22
Bothell, Washington, United States
Senior Associate, Quality Assurance
Quality
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.
 

POSITION SUMMARY:

The incumbent is responsible for developing the incoming/final product and raw material receipt and disposition processes for the GMP Bothell Manufacturing Site. This role will work closely with the GMP Site Team to implement the electronic Manufacturing Execution System (MES) and specialize in the disposition processes. Once GMP Manufacturing operations are initiated, this individual will continue to perform routine Quality Assurance tasks including but not limited to batch record review, raw material disposition, deviation, CAPA, and change control approval, product change over, and other Quality Operations functions.

KEY ROLE AND RESPONSIBILITIES:

Startup GMP Facility and Operations

  • Collaborate with key stakeholders and electronic system owners on the
    development of the material disposition processes for incoming apheresis, raw
    materials, and final products. Create corresponding SOPs.
  • Work with the Manufacturing Execution System (MES) Design Team on
    developing manufacturing processes, chain of identity, raw material receipt and
    disposition, and understanding manufacturing operations.
  • Perform Quality approval of electronic batch records via the MES system.
  • Develop “review by exception” with Quality Systems experts.
  • Represent Quality Assurance on project specific teams for clinical products.
  • Work with MES teams and materials management to develop the raw material
    receipt and disposition processes.
  • Collaborate with stakeholders on raw material specifications.
  • Collaborate on the development of all raw material systems.

Execute the Day-to-Day Quality Assurance Operations

  • Review and approve executed electronic batch record exceptions and resolve
    discrepancies with manufacturing personnel.
  • Provide quality support for manufacturing operations in the cleanroom facilities.
  • Perform routine QA activities including incoming patient apheresis review and
    release and final product review and disposition. 
    • Perform routine raw material review and disposition and approval of raw
      material specifications.
    • Perform internal audits as required.
    • Support routine quality operations as required as the site maturest.

 PREFERRED EDUCATION:

  • BSc degree with 7 years’ experience in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field)

   PREFERRED EXPERIENCE:

  • 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+
    years in GMP quality

 KNOWLEDGE, SKILLS AND ABILITIES:

  • Experience in clinical manufacturing.
  • Experience with quality management systems (e.g. deviations, CAPAs, change
    management).
  • Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and
    inter-personal skills.
  • The desire and ability to work in a fast-paced, start-up environment.
  • Motivated and organized critical thinker with solid interpersonal and business
    communication skills.
  • Demonstrated ability to work effectively with a team to set goals, develop sound project
    plans, monitor progress, and report results.
  • Ability to work efficiently, prioritize workflow, meet deadlines and balance competing
    priorities.
  • Excellent analytical skills and scientific/technical expertise.

Shift Work, Weekend Work and Holiday Coverage:

Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work and holiday work will be required. 

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.

Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
 
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.
 
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