Manager, Quality Assurance

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:

You will be responsible for the day-to-day Quality Assurance operations for the manufacturing facility and providing leadership and oversight for the Quality Assurance team.   This role will collaborate closely with the LyFE GMP Manufacturing Center teams continued implementation and improvement to GMP processes, and will specialize in the drug product batch disposition process.  You will support and perform routine Quality Assurance tasks including but not limited to, batch record review, raw material disposition, drug product disposition, deviation, CAPA, and change control approval, product change over, and other Quality Operations functions. 

KEY ROLE AND RESPONSIBILITIES:

• Responsible for the supporting Quality oversight of GMP operations at the manufacturing facility and ensuring adherence to applicable GMP regulations and Lyell policies and procedures.
  • Review and approve executed electronic batch records and exceptions and identify and investigate deviations with manufacturing personnel.
  • Provide on the floor quality support for manufacturing operations in the cleanroom facilities during operations, including non-routine working hours.
  • Perform routine QA activities including incoming patient apheresis review and final product review and disposition.
  • Perform routine raw material review and disposition and approval of raw material specifications.
  • Work with the Manufacturing Execution System (MES) Team to continuously improve manufacturing batch records.
  • Represent Quality Assurance on project specific teams for clinical products.
  • Collaborate with other leaders at the site to assist in the continuous improvement and lifecycle management of GMP procedures.

 PREFERRED EDUCATION:

• BSc with a minimum of 10 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field; or
• MSc with a minimum of 7 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field

 PREFERRED EXPERIENCE:

• 8 - 10 years of experience in GMP biopharmaceutical operations
• A minimum of 5 years’ experience in GMP quality
• Experience in early clinical phase manufacturing
• Experience with quality management systems (e.g. deviations, CAPAs, change management)

 KNOWLEDGE, SKILLS AND ABILITIES:

• Extensive knowledge of regulations for GMP manufacturing of drug substance, drug products, and cellular and gene therapies.
• We operate a paperless manufacturing facility requiring proven knowledge of and the ability to work effectively with electronic systems
• Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and interpersonal skills.
• The desire and ability to work in a fast-paced, start-up environment.
• Motivated and organized critical thinker with strong communication skills.
• Demonstrated ability to work effectively with a team to set goals, develop sound project plans, monitor progress, and report results.
• Demonstrated ability to hire, coach and grow technical talent.
• Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.

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. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us.  Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.

 

 

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.