Process Development and Manufacturing Scientist
The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University School of Medicine is seeking a Process Development and Manufacturing (PDM) Scientist 3. The LCGM is a ~20k ft2 multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children’s Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.
This position will join a stellar team of PDM Scientists and will 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. This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.
• Lead development activities for new processes and procedures for first-in human clinical materials development including design of process scale-up and scale-out, closed systems and engineering runs to meet clinical materials requirements.
• Lead clinical materials manufacturing campaigns; responsible for oversight and coordination of junior staff in conducting all activities related to manufacturing; lead decision-making when collaborating 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), cGMP-level work conditions and adherence to corresponding requirements.
• Develop standard operating procedures (SOPs), Batch Records and product specifications. Critically assess experimental data, provide interpretation of results, and ensure data quality and integrity. Present data to functional manager and collaborative groups to support product and process specification.
• Author or co-author of manuscripts for publication in peer-reviewed journals. Remain current on literature and standard industry practices by attending scientific meetings/conferences.
• Provide support for regulatory filings including drafting Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (IND) Regulatory Filing.
• May manage two or more staff in day-to-day operations for functional area(s) of responsibility. Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the 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.
• May serve as safety officer; responsible for ensuring implementation of EH&S, fire and city regulations for laboratory safety.
*- Other duties may also be assigned
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.
• 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.
• 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.