Process Development & Manufacturing Associate Scientist
Location: Stanford, California
Internal Number: 97717
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.
Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $107,000 to $137,000.
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.
Why work at Stanford?Stanford University has changed the world, over and over again.We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career.At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment. How will it change you?