iHire is hiring: Manufacturing Scientist in Brisbane

Overview

Manufacturing Scientist (100% FTE) at iHire, in partnership with Stanford University. The Stanford Center for Cancer Cell Therapy (CCT) seeks a Clinical Manufacturing Scientist (PDM3) to provide highly specialized technical research, support and expert consultation for clinical cell and gene therapy manufacturing, aligned with cGMP and the clinical trial investigational phase.

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 cross-functional collaboration with operations, regulatory affairs, quality systems, and business & administration; maintain 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) conditions and adherence to requirements.
• Develop SOPs, Batch Records, and product specifications. Interpret experimental data, ensure data quality and integrity, and present data to leadership and collaborators to support product/process specifications.
• Train and supervise Manufacturing Associates and Specialists; may manage two or more staff; handle hiring, coaching, and performance management; ensure work completion within schedules.
• May liaison with senior management, cross-functional areas, schools and external organizations (sponsors, government agencies).
• Co-author manuscripts for publication; stay current on literature and industry practices by attending scientific meetings/conferences.
• Participate in discussions with internal/external collaborators, providing analyzed data and review as appropriate; collaborate with CCT Process Development and Manufacturing teams.
• May serve as safety officer; ensure EH&S, fire and laboratory safety compliance.

Qualifications

• Bachelor's degree in chemistry, microbiology, biological sciences, etc., 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 documentation for clinical manufacturing of cell/gene therapies preferred.
• Experience with tech transfer; engineering/qualification runs is a plus.
• Ability to occasionally work evenings and/or weekends based 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 a 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.
• Experience with aseptic cell culture.
• cGMP clean room experience.
• Strong computer skills and ability to learn software, databases, and scientific applications.
• Ability to work independently, maintain relationships, and provide ongoing reporting to management.
• Excellent organizational skills and attention to detail.

Physical Requirements

• Frequent sitting, fine hand manipulation, repetitive pipetting, desk-based computer tasks; ability to lift up to 15 pounds.
• Reasonable accommodation provided for applicants with disabilities upon request.

Working Conditions

• May require work near bloodborne pathogens; deadlines and unpredictable manufacturing schedules.
• Work in areas with hazardous materials and infectious agents; cGMP clean room environment.
• May handle viruses (lentiviruses, AAV, retroviruses) and human embryonic stem cells (hESCs).
• Personal protective equipment required; may be exposed to high voltage, radiation, lasers, noise, biohazards, chemicals, and confined spaces.
• Extended or unusual hours may be required to support manufacturing expectations.

Work Standards

• Interpersonal skills: collaborate effectively with Stanford colleagues, clients, and external partners.
• Promote safety culture: uphold safety responsibilities and communicate concerns; follow training and lessons learned.
• Comply with University policies and procedures, including personnel policies and related guidelines.

The expected pay range for this position is $132,295 to $151,056 per annum. Stanford provides pay ranges as a good faith estimate, with actual offers determined by scope, qualifications, budget, internal equity, location, and external market.

Stanford University 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. Reasonable accommodations for applicants and employees with disabilities are available through Stanford University Human Resources.

The job duties listed are typical examples and not a comprehensive inventory of all duties. Specific duties may vary by department or program needs.

Equality and diversity are core to Stanford’s mission and we encourage applicants from all backgrounds to apply.