Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. At Lyell, our goal is to change that. We are a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for solid tumors based on our innovative technologies. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to defeat solid tumors, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission’s urgency.
We are seeking a Quality Assurance Associate to support the Quality Assurance (QA) operations at the Lyell Manufacturing Center (LyFE) located in Bothell, WA. Scope of work includes, but is not limited to ,Asset Management, Batch Records, Deviation and CAPA, GMP Cleanroom Support, Raw Materials. Ideally seeking someone with 3+ years of cGMP experience in GMP biopharmaceutical operations and with prior experience in a GMP Quality role
KEY ROLE AND RESPONSIBILITIES:
- Collaborate with key stakeholders and system owners on the continuous improvement of the Quality GMP processes at LyFE
- Implementation of GMP Quality Operations
- Create and/or collaborate on corresponding SOPs
- Represent Quality Assurance on project specific teams, as needed
- Execute Routine Quality Assurance Operations
- Perform review and approval of executed electronic batch records, and resolution of discrepancies with manufacturing personnel
- Perform review and approval of Deviation and CAPA record deliverables
- Provide quality support for manufacturing operations in the cleanroom facilities (e.g.,changeover/line clearance support, APH receipt, product pack-out, event triage)
- Perform review and disposition of incoming raw materials, and approval of raw material specifications
- Author and/or collaborate on the creation, revision, and obsoletion of Standard Operating Procedures across the LyFE site.
- Perform review and approval of asset induction/release deliverables, on-demand work, and non-conformances.
- Support other routine Quality operations as required, commensurate with experience and the LyFE site maturation
PREFERRED EDUCATION:
- Associate’s or Bachelor’s degree or an equivalent combination of education and work experience, preferably in a cell therapy environment
PREFERRED EXPERIENCE:
- 3+ years of cGMP experience in GMP biopharmaceutical operations and with prior experience in a GMP Quality role
- Experience in clinical manufacturing
- Experience with quality management systems (e.g. deviations, CAPAs, change management)
KNOWLEDGE, SKILLS AND ABILITIES:
- 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
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
- Confirm visual information in the environment such as; batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product.A vision test may be required.Use of corrective lenses is acceptable.
- Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.
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.
Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.
The salary range for this position is $34.62 to $38.46 hourly, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits offering can be found on our company website, www.lyell.com
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.