Specialist, Quality Control

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:

You will be responsible for supporting Quality Control (QC) operations at the Lyell Manufacturing Center (LyFE) located in Bothell, WA. Scope of work includes in-process and release testing of drug substance and drug product, with a focus on Cell Biology and Flow Cytometry. Transfer and qualification of QC methods from Analytical Development and Quality System support including, leading deviation investigations, initiating and driving change controls and CAPA. The candidate must be familiar with and comfortable with the use of electronic system.

KEY ROLES AND RESPONSIBILITIES:

• Lead QC projects related to qualification and/or validation of new method or improved method technologies.
• Author and/or collaborate on the creation and revision of Standard Operating Procedures, qualification protocols and test methods for QC and cross-functionally.
• Support day-to-day QC activities, including in process and release testing of raw materials, drug substance and drug product.
• Perform review and approval of QC data.
• Initiate and lead, Deviations, Change Controls and CAPA.
• Support the QC supervisor in other routine Quality Control operations as required.
• Perform equipment maintenance as required.
• Use strong communication and build 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

PREFERRED EXPERIENCE:

• Minimum 8-10 years of experience in GMP biopharmaceutical operations, preferably with experience in cell therapy, cell biology and flow cytometry, with a minimum of 4 years in a GMP Quality role
• Experience with electronic quality management systems (e.g., Deviations, Change Controls, CAPAs etc.)
• Experience with electronic LIMS systems e.g., Labvantage, Labware

KNOWLEDGE, SKILLS, AND ABILITIES:

• Experience working in GMP manufacturing of drug substance and drug products.
• Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills
• Strong communication skills to represent QC 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.

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.

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.  

 

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.