Process Development and Manufacturing Scientist
The Laboratory for Cell & Gene Medicine (LCGM) is seeking a Process Development & Manufacturing Professional 4 to support on-going manufacturing and lead translational development for novel cell-based therapy for use in clinical trials; provide highly specialized technical research, support and expert consultation including innovating and designing solutions for unique process development and product 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. LCGM is a purpose-build cGMP facility at Stanford School of Medicine that supports cellular therapy process development and manufacturing across diverse clinical specialties. Join this exciting team at LCGM!
- Provide leadership, scientific technical and subject matter expertise to oversee and manage process development and manufacturing activities including planning and implementation of major projects, clinical materials manufacturing activities, process development in translational medicine, services and facilities-related issues.
- Provide scientific leadership across all functional teams by overseeing and directing project development and management and budgeting oversight; collaborating and liaising with clinical investigators; consulting with and driving solutions for major projects with broad, significant clinical impact based on experience and subject matter expertise.
- Create new industry standards and best practices; direct and develop technical scientific elements of regulatory filings (i.e., chemistry, manufacturing and controls); develop and maintain relationships with vendors to evaluate devices, supplies and materials relevant to process development and manufacturing.
- Author or co-author articles, presentations, or scientific papers for peer review journals and/or presentation at national/international scientific meetings/conferences. Write, submit and address reviewer comments related to novel methods in process development and manufacturing.
- Identify research and development funding opportunities.
- Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
- 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 safety officer; responsible for ensuring implementation of EH&S, fire and city regulations for laboratory safety.
*- Other duties may also be assigned
- Advanced degree in biology or other related field.
- Hands-on experience with iPSCs.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor’s degree in related scientific field and 6 years relevant experience; or Master’s degree and four years of related experience or an equivalent combination of education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Thorough knowledge of the principles of molecular biology, biological process engineering
- Demonstrated project management experience
- Understanding of principles and compliance with cGMP, raw materials and documentation requirements
- Demonstrated cGMP clean room oversight and management
- 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.
- 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.