Stanford University (US) 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 unique activities related to clinical cell and gene therapy 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.

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 CAR T therapies.
• Lead clinical materials manufacturing campaigns; oversee and coordinate junior staff in manufacturing activities; lead decision-making when collaborating with 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 adherence to corresponding requirements.
• Develop standard operating procedures (SOPs), Batch Records, and product specifications; critically assess experimental data, interpret results, ensure data quality and integrity; present data to functional manager and collaborative groups 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, career coaching, personal development, and performance of employees. Ensure work completion within schedules and constraints.
• May serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
• Co-author manuscripts for publication in peer-reviewed journals; remain current on literature and standard industry practices by attending scientific meetings/conferences.
• Participate in discussions with internal and external collaborators, providing analyzed data and review when appropriate.
• Participate in discussions with CCT Process Development and Manufacturing teams, providing analyzed data and feedback when appropriate.
• May serve as safety officer; responsible for ensuring EH&S, fire and city regulations for laboratory safety.

The Center for Cancer Cell Therapy is part of the Stanford Cancer Institute (SCI), an elite National Cancer Institute-Designated Comprehensive Cancer Center. SCI works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.

Desirable 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 required.
• cGMP experience strongly preferred.
• Previous supervisory or management experience desired.
• Experience with CAR T, TCR, T cells, gene editing, and cell and gene therapy process development/manufacturing desired.
• Knowledge of SOPs, batch records, and other documentation for clinical manufacturing of cell and gene therapy products preferred.
• Experience with tech transfer; engineering/qualification runs a plus.
• Ability to occasionally work into the evening and/or weekends, depending on 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, 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 require work 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).
• Use of personal protective equipment (PPE) such as safety glasses, clothing, 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.

Work Standards

• Interpersonal skills: work well with Stanford colleagues, clients, and external organizations.
• Promote culture of safety: commit to personal responsibility and safety; communicate safety concerns; promote safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies, including personnel policies as found in the University’s Administrative Guide.

The expected pay range for this position is $132,295 to $151,056 per annum. Salary decisions are based on factors including scope, qualifications, budget, internal equity, location, and market.

Stanford University provides pay ranges as part of its rewards package. Details about benefits are discussed during the hiring process. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

The job duties listed are typical examples and are not a comprehensive inventory of all duties. Duties may vary depending on department needs. Employees may also perform other duties as assigned.