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Senior Associate, MSAT
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. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. 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 advance next-generation CAR T-cell therapies, 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.
POSITION SUMMARY:
The incumbent is responsible for supporting the ongoing operations of the Manufacturing, Science and Technology (MSAT) team within the manufacturing site. This role will primarily be responsible for real time process and equipment troubleshooting and critical manufacturing support activities including investigations, change controls, CAPAs, process capability, capacity, electronic batch records, efficiency and quality improvements.
KEY ROLE AND RESPONSIBILITIES:
Technical Support, Investigations and routine operations
- Provide real-time technical support including process and equipment troubleshooting to
- Provide real-time technical support for Aseptic Process Validation, training, and engineering runs as needed.
- Facilitate and maintain particle/particulate identification library.
- Provide technical support for deviation management, lot disposition, batch record reviews so that technical issues stay off the critical path for reliable supply.
- Assist with CAPA and change controls as
- Facilitate cross functional team to drive operational excellence and continuous improvement.
Equipment Identification, Qualification, and Support
- Provide technical support and assist during the equipment onboarding phase as needed.
- Assist with a cross-functional team to ensure appropriate equipment selection and procurement as needed.
- Assist with equipment installation, commissioning, and qualification as needed.
Product, Process, and Technology Transfers and Changes
- Assist with transfers of new products and processes to ensure smooth transition from process development into GMP manufacturing as needed.
- Train Manufacturing staff as necessary on new unit operations and processes being
- Provide support for the MSAT team and cross-functional project teams in areas of facility fit, gap analysis, FMEA risk assessment, troubleshooting and investigation.
- Assist in documenting changes/updates to manufacturing processes and work with cross-functional teams to implement those changes.
- Support the development, validation, and revision of electronic batch records as
General Responsibilities
- Maintain appropriate level of training for assigned
- Identify, communicate, and help mitigate identified risks that could negatively impact the quality or delivery of patient therapies.
PREFERRED EDUCATION:
- BA/BSc with a minimum of 4 years’ experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing; or
- MBA or MSc with a minimum of 2 years’ experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing
PREFERRED EXPERIENCE:
- Experience in technical roles within a GMP biopharmaceutical manufacturing operation, experience working in process development is a plus.
- Experience with manufacturing automation and MES software
- Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
KNOWLEDGE, SKILLS AND ABILITIES:
- Working knowledge with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
- Strong collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.
- Proven track record in a cGMP environment with the skills to promote a culture of safety and GMP compliance.
- Fast learner, adaptable, and excellent cross-collaboration and inter-personal
- Proven ability to build strong relationships with Quality to ensure a compliant manufacturing environment.
- Demonstrated ability to be a team player, offer assistance, and respond well to requests for help from team members.
- Ability to support operational excellence
- Identify opportunities for continuous
- The desire and ability to work in a fast-paced, start-up
- Proficient in MS Office and a preference for working knowledge with statistical software (R, JMP or Minitab).
- Proven ability to effectively lead projects in a fast-paced
- Excellent written and verbal communication skills
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.
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 $45.43 to $48.08 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.
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.
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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