Manufacturing Scientist Job at iHire in Santa Clara

Manufacturing Scientist (100% FTE) — Stanford Center for Cancer Cell Therapy (CCT)

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 CART therapies.
• Oversee and coordinate junior staff in manufacturing activities; lead decision-making when collaborating with operations, regulatory affairs, quality systems, and business/administration; provide regular reporting to the functional manager.
• Develop methods for, perform, and supervise manufacturing of clinical materials according to cGMP standards in Biosafety Level 2 (BSL2) and maintain adherence to related requirements.
• Develop SOPs, Batch Records, and product specifications; critically assess experimental data, interpret results, ensure data quality and integrity, and present data to the functional manager and collaborators.
• Train and supervise Manufacturing Associates and Specialists; may manage two or more staff; responsible for hiring, coaching, and development of direct reports; ensure work completion within schedules.
• Serve as liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies as needed.
• Co-author manuscripts for publication; stay current on literature and industry practices by attending scientific meetings and conferences.
• Participate in discussions with internal and external collaborators and provide analyzed data and feedback when appropriate.
• Participate in discussions with CCT Process Development and Manufacturing teams, providing analyzed data and feedback when appropriate.
• May serve as safety officer; ensure implementation of EH&S, fire and city regulations for laboratory safety.

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 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 evenings and/or weekends depending on 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 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 and use databases and scientific applications; ability to work independently and provide ongoing reporting to management.
• Excellent organizational skills and attention to detail.

Physical Requirements

• Frequently sit, grasp, perform pipetting, and perform desk-based computer tasks; lift up to 15 pounds.
• Reasonable accommodations provided as required by law.

Working Conditions

• May require working near blood-borne pathogens; deadlines and unpredictable manufacturing schedules.
• May work in areas with hazardous materials and infectious diseases; work in a cGMP clean room environment; may work with viruses and human embryonic stem cells.
• Personal protective equipment (glasses, clothing, gloves, and possibly respirator) may be required; potential exposure to high voltage, radiation, noise, biohazards, and chemicals; may require extended or unusual hours.

Work Standards

• Interpersonal skills to work with Stanford colleagues, clients, and external organizations.
• Promote a culture of safety; prioritize safety and compliance with training and lessons learned.
• Compliance with University policies and procedures; performance may vary by department needs.

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 and determines the final offer based on scope, qualifications, departmental budget, and market considerations. 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.

The job duties listed are typical examples and not a comprehensive inventory of all duties. Specific duties may vary; employees may perform other duties as assigned.