Process Development Specialist

The Stanford Cancer Institute at Stanford University is seeking a Clinical Process Development & Manufacturing Professional 2 to independently conduct major portions of complex process development and clinical materials biomanufacturing consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.

Duties include

Lead human clinical materials biomanufacturing campaigns primarily as an operator. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.

Coordinate campaign activities with all functional teams : operations, quality systems, regulatory affairs, and business & administration.

Train on biomanufacturing procedures, Batch Records or provide direction during process development activities.

Plan and perform complex components of process development for technology transfer, scale-up / scale-out, optimization activities and characterization of new, state-of-the-art technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials.

Plan and perform upstream and downstream components of assigned cGMP projects.

Identify strategies for innovation in production systems and manufacturing processes.

Identify operating excursions and facility deficiencies during manufacturing. Determine deviations and provide recommendations for Corrective and Preventive Action (CAPA) for Batch Records.

Develop manufacturing budget including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outline overall and per / patient costs for project materials and supplies and hours dedicated to complete all manufacturing steps.

Determine need for, devise and revise Standard Operating Procedures and Batch Records.

Oversee cGMP grade raw materials acquisition for biomanufacturing.

Prepare and submit abstracts for publication in peer-reviewed journals and / or presentation at scientific conferences.

• Other duties may also be assigned.

EDUCATION & EXPERIENCE (REQUIRED) :

Bachelor's degree in related scientific field and two years of related experience, or Master’s degree, or an equivalent combination of education and relevant work experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED) :

Strong biological scientific background.

Working experience with aseptic cell culture.

cGMP clean room experience.

Strong computer skills and ability to learn quickly and master computer programs, databases and scientific applications.

Ability to work under deadlines with minimal supervision.

Ability to maintain relationships and communicate effectively.

Excellent organizational skills and demonstrated ability to complete detailed work.

PHYSICAL REQUIREMENTS

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.

WORKING CONDITIONS :

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, working at heights.

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.

WORK STANDARDS :

Interpersonal Skills : Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.

Promote Culture of Safety : Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors bases on training and lessons learned.

Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide,

http : / / adminguide.stanford.edu

The expected hourly pay range for this position is $47.72 to $53.23.

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.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (

https : / / cardinalatwork.stanford.edu / benefits-rewards

) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a

contact form

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 of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.