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Quality Assurance Specialist
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 Respect, Science, Courage and Collaboration and it reflects who we are and the environment we are creating.
We are seeking a Quality Assurance, Specialist 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, drug substance and drug product lot disposition, batch record review, GMP cleanroom support, raw material management, and Quality System support including system integration deliverables, deviation, change control, and CAPA review and approval.
KEY ROLE AND RESPONSIBILITIES:
- Collaborate with key stakeholders and system owners on the continuous improvement of the Quality GMP processes at LyFE
- QA lead for projects related to optimization of Manufacturing Execution System (MES) processes, recipe approval and chain of identity controls
- Support cross-functional projects related to the integration of electronic systems
- Author and/or collaborate on the creation and revision of Standard Operating Procedures (SOPs) across the LyFE site
- Support lot disposition activities, including the review and approval of executed electronic batch records, ensuring resolution of discrepancies with manufacturing personnel
- Perform review and disposition of incoming raw materials as well as approval of raw material specifications
- Provide on-site quality support for manufacturing operations in the cleanroom facilities (e.g., changeover/line clearance support, APH receipt, product pack-out, event triage)
- Lead QA actions related to technology transfer activities for onboarding of new processes within the manufacturing facility
- Ad-hoc support of qualification and validation projects throughout the facility
- Perform review and approval of Change Management deliverables, as applicable
- Perform review and approval of Deviation and CAPA record deliverables, as applicable
- Support other routine Quality operations as required, commensurate with experience and the LyFE site maturation
- BSc degree with 7 years’ experience in biology, biochemistry, chemical engineering, bioengineering, or related technological field
- MSc degree with 4 years’ experience in biology, biochemistry, chemical engineering, bioengineering, or related technological field
- A minimum of 6 years in GMP biopharmaceutical operations with a minimum of 4+ years in a GMP Quality role. • Experience in clinical manufacturing
- Experience with quality management systems (e.g. deviations, CAPAs, change management).
KNOWLEDGE, SKILLS AND ABILITIES:
- Experience in clinical manufacturing
- Experience with quality management systems (e.g. deviations, CAPAs, change management)
- Experience building GxP raw material management programs preferred
- Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills
- Strong communication skills to ensure issues, risks and resolutions are promptly shared with the LyFE cross-functional teams
- Strong technical writing skills
- 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 own projects, work effectively with a team to set goals, develop sound project plans, monitor progress, and report results
- Ability to work efficiently, prioritize workflow, set and meet deadlines as well as balance competing priorities
- Excellent analytical skills and scientific/technical expertise
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 $108,000 to $120,000, annually, 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.