Senior Associate of CMC Operations (On-site)
The Stanford Cancer Institute - Cancer Cell Therapy Center at Stanford University is seeking a Clinical Process Development & Manufacturing Professional 3 to provide highly specialized technical research, support and expert consultation including identifying, innovating and designing solutions for unique process development and manufacturing activities related to clinical materials manufacturing. Work is to be consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.
Duties include*:
- Oversee CMC operations for CCT GMP manufacturing, coordinating with internal and external CMOs, managing sample shipment and tracking, and ensuring regulatory compliance. Coordinate end-to-end manufacturing activities, from apheresis collection to final product release and delivery for clinical infusion, while managing collaborations with external teams and clinical partners.
- Create and manage the CCT manufacturing schedule for CAR-T programs, ensuring alignment with clinical trial needs and regulatory compliance.
- Contribute to CCT (Center for Cancer Cell Therapy) human clinical materials biomanufacturing campaigns as an operator or verifier. Prepare final formulated cellular products for cancer therapy clinical trials within production timelines and manufacturing schedules. Mainly focused on CART therapies.
- Lead decision-making when collaborating with functional teams: operations, regulatory affairs, quality systems, business & administration; maintain regular reporting to functional manager.
- Manage apheresis, intermediate, and final product inventory in collaboration with internal teams and external storage providers. Oversee stock tracking, maintain inventory records, verify invoices, and serve as the primary contact for external storage facilities regarding inventory management, shipments, and product disposition.
- Provide support for regulatory filings including drafting Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (IND) Regulatory Filing.
- Review and analyze trends to advise and develop recommendations to achieve or modify the goals of the program or function.
- May serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
- Inform training required for CMC Ops and Regulatory Affairs staff within CCT.
*- Other duties may also be assigned.
DESIRED QUALIFICATIONS:
- Bachelor's degree in chemistry, microbiology, biological sciences, etc. with 4 years of experience. Or Master’s degree in related field with 2 years of experience.
- Aseptic technique and cell culture experience is required.
- cGMP experience is strongly preferred.
- Previous supervisory or management experience is desired.
- Experience with CAR T, TCR, T cells, gene editing, and cell and gene therapy process development/manufacturing desired.
- Knowledge of and experience generating SOPs, batch records, and other documentation for clinical manufacturing of cell and gene therapy products is preferred.
- Experience with tech transfer, engineering/qualification runs a plus.
- Ability to occasionally work into the evening and/or on weekends, depending on clinical manufacturing schedules.
- Experience with following assays a plus: cell culture, ELISA, tumor-killing assays, flow cytometry/CyTOF/FACS, qPCR/PCR, gene editing/CRISPR.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field and four years of related experience, or Master’s degree and two years of related experience or an equivalent combination of education and relevant work experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent understanding of scientific principles.
- Working experience with aseptic cell culture.
- cGMP clean room experience.
- Excellent computer skills and ability to learn quickly and master computer programs, databases and scientific applications.
- Ability to work independently, maintain relationships and provide ongoing reporting to functional management.
- Excellent organizational skills and demonstrated ability to complete detailed work.
PHYSICAL REQUIREMENTS*:
- Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.
*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
WORKING CONDITIONS:
- May require working in close proximity to blood borne pathogens.
- Ability to work under deadlines and meet/ exceed unpredictable manufacturing schedules.
- Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
- Position requires working in a cGMP clean room environment.
- Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
- Position may work with human embryonic stem cells (hESCs).
- Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
- May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/ Chemicals, and confined spaces.
- May require extended or unusual work hours based on clinical manufacturing requirements and business needs. May be required to stay at work until product is released.
WORK STANDARDS:
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors bases on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide.
