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Quality Control Associate II
Bothell, Washington, United States
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.
SUMMARY:
This is a shifted, hourly position requiring on-site presence Wednesday-Saturday, from 12:00N -10:30PM, with the potential for occasional overtime.
The candidate will support Quality Control (QC) operations at the Lyell Manufacturing Center (LyFE) in Bothell, WA. The scope of work includes in-process and release testing of cellular drug products, focusing on Flow Cytometry and Cell-Based Assay activities. Sample Management or Environmental Monitoring experience is a plus. The ideal candidate must be comfortable using electronic systems such as LIMS and Regulatory Asset Management Systems.
KEY ROLES AND RESPONSIBILITIES:
- Support routine QC Analytic activities, including in-process, stability, and release testing of raw materials, substances, and products.
- Support electronic Sample Management activities, including sample receipt, shipping, and delivery, and managing multiple stability programs and inventory control.
- Support routine QC Micro activities, including routine Environmental Monitoring of the GMP Facility.
- Perform equipment maintenance.
- Support QC Management in other routine Quality Control operations as required.
- Build strong communication and collaborative relationships across LyFE and the other Lyell sites.
- Demonstrate technical acumen, operational understanding, and GMP compliance.
- Support operational excellence initiatives.
- Promote a culture of safety and GMP compliance.
- Identify opportunities for continuous improvement.
PREFERRED EDUCATION:
- Bachelor’s degree or equivalent in biology, biochemistry, bioengineering, microbiology or related technological field or equivalent combination of education and experience, post-graduate coursework desirable
- Minimum 2-3 years of experience in cell therapy GMP QC operations.
- Experience with electronic quality management systems (e.g. MasterControl).
- Experience with electronic GMP operating systems (e.g., Labvantage, Labware, BMRAM, REES).
PREFERRED EXPERIENCE
- 1-3 years of experience in GMP Flow Cytometry and/or Cell-Based Assays
- Experience in Sample Management or Environmental Monitoring is a plus
- Experience collaborating and/or authoring GMP documents (Test Methods, Deviation Initiation, SOPs).
KNOWLEDGE, SKILLS, AND ABILITIES:
- Experience working in GMP manufacturing of drug substances and drug products.
- Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and interpersonal skills.
- Can operate independently in the laboratory with minimal supervision.
- Strong communication skills to represent QC with the site 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 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, and balance competing priorities.
- Intermediate analytical skills and scientific/technical expertise are expected.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to perform the essential functions of the job successfully. 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.
Shift Work, Weekend Work, and Holiday Coverage:
On-site, Wednesday-Saturday from 12Noon -10:30PM.
Due to the nature of 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 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 - $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 include 18 days’ vacation, nine days’ sick leave, eight observed holidays, and a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits offering can be found here.
At Lyell, we believe that the highest performing teams include people from various 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.
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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