Senior Associate, MSAT

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 a