Stanford Blood Center is hiring: Manufacturing Scientist in Stanford

Overview

Manufacturing Scientist (100% FTE). The Stanford Center for Cancer Cell Therapy (CCT) is seeking a Clinical Manufacturing Scientist (PDM3) to provide highly specialized technical research, support and expert consultation including identifying, innovating, and designing solutions for activities related to clinical cell and gene therapy manufacturing. Work is to be consistent with current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.

Responsibilities

• Lead CCT 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 clinical materials manufacturing campaigns; oversee and coordinate junior staff; lead decision-making with functional teams (operations, regulatory affairs, quality systems, business & administration); maintain regular reporting to functional manager.
• Develop methods for, perform, and supervise manufacturing of clinical materials according to cGMP standards in Biosafety Level 2 (BSL2) environments and ensure compliance with requirements.
• Develop standard operating procedures (SOPs), batch records, and product specifications. Assess experimental data, interpret results, ensure data quality and integrity, and present data to management and collaborators to support product and process specifications.
• Train and supervise Manufacturing Associates and Specialists. May manage two or more staff in day-to-day operations; responsible for hiring, coaching, and career development; ensure work is completed within schedules.
• May serve as liaison to senior management and cross-functional areas, schools and external organizations such as sponsors and government agencies.
• Co-author manuscripts for publication in peer‑reviewed journals and remain current on literature and industry practices by attending meetings/conferences.
• Participate in discussions with internal and external collaborators, providing analyzed data and reviews as appropriate; participate in discussions with CCT Process Development and Manufacturing teams for data and feedback.
• May serve as safety officer; responsible for implementing EH&S, fire and laboratory safety regulations.

Desired Qualifications

• Bachelor's degree in chemistry, microbiology, biological sciences, or related field with 4 years of experience; or Master’s degree 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 is 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 are a plus.
• Ability to occasionally work into the evening and/or on weekends, depending on clinical manufacturing schedules.
• Experience with assays such as cell culture, ELISA, tumor-killing assays, flow cytometry/CyTOF/FACS, qPCR/PCR, gene editing/CRISPR is a plus.

Education & Experience (Required)

Bachelor's degree in related scientific field with four years of related experience, or Master’s degree with 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, perform fine hand manipulation, repetitive pipetting, desk-based computer tasks, and lift/carry/push/pull objects up to 15 pounds.

Working Conditions

• May require working in close proximity to blood borne pathogens.
• Ability to work under deadlines and meet unpredictable manufacturing schedules.
• Position may require working with hazardous materials and infectious diseases; work in a cGMP clean room environment.
• Position may involve working with viruses (lentiviruses, AAV, retroviruses) and human embryonic stem cells (hESCs).
• Employee must use personal protective equipment and may be exposed to hazardous conditions (voltage, radiation, noise, allergens, biohazards, chemicals) and confined spaces.
• May require extended or unusual work hours based on clinical manufacturing requirements and business needs, including staying until product is released.

Work Standards

• Interpersonal Skills: ability to work well with Stanford colleagues, clients and external organizations.
• Promote Culture of Safety: commit to safety, report concerns and follow training and lessons learned.
• Compliance: adhere to all applicable University policies and procedures.

The expected pay range for this position is $132,295 to $151,056 per annum. Stanford University provides pay ranges as a good faith estimate of compensation. Details about rewards and benefits are discussed during the hiring process.

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Job duties listed are typical examples and not a comprehensive inventory of all duties. Specific duties may vary by department or program needs. Other duties may be assigned.