Clinical Process Development & Manufacturing Professional 1

DESIRED QUALIFICATIONS:

• Knowledge and following SOPs and batch records preferred.
• Aseptic technique and cell culture experience preferred
• Experience with viral vector production, molecular biology, upstream and downstream processing preferred
• cGMP experience is preferred 
• Ability to occasionally work into the evening and/or on weekends, depending on clinical manufacturing schedules

EDUCATION & EDUCATION (REQUIRED):

Bachelor's degree in related scientific field or an equivalent combination of education and experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong understanding of biological scientific principles
• 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.

• Maintain knowledge of cGMP environment requirements.

CERTIFICATIONS & LICENSES:

None

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.

*- 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.

WORKING CONDITIONS:

• May require working in close proximity to blood borne pathogens.
• Ability to work with 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 primarily requires working in a cGMP clean room environment. 
• Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
• Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves. 
• 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

The Stanford Laboratory for Cell & Gene Medicine (LCGM) is seeking a Clinical Process Development & Manufacturing Professional I (Manufacturing Assistant/Associate) focused on clinical Viral Vector products. LCGM is a GMP 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.

LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. We invite you to join our team!

Learn more about our team here: https://med.stanford.edu/lcgm.html

Duties include: 

• Plan, prepare for and perform viral vector materials biomanufacturing campaigns typically as an operator or a verifier. Prepare final formulated viral vector products for clinical trials within production timelines and manufacturing schedules.

• Perform components of process development and technology transfer for viral vector production, and optimization activities in transitioning and translating pre-clinical, benchtop research into clinical phase. This includes testing and process optimization for upstream and downstream processing at the small scale manufacturing platforms and using novel bioreactors. 

• Help with general lab maintenance as needed; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed
• Identify, document and report operating excursions and facility deficiencies; make recommendations for process improvements and documentation improvements including Standard Operating Procedures (SOP) and manufacturing Batch Records (BRs). 
• Independently track, verify and ensure cGMP grade raw materials for biomanufacturing. Identify and plan for supply chain and raw materials lead times for scheduled campaigns. 

• Perform preparation activities of assigned cGMP manufacturing projects. 

*- Other duties may also be assigned

Responsibilities

Core Duties:

• Plan, prepare for and perform human clinical materials biomanufacturing campaigns typically as a verifier. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.

• Plan and perform components of process development and technology transfer for manufacturing of clinical materials, scale-up/scale-out and optimization activities in transitioning and translating pre-clinical, benchtop research into phase appropriate clinical trials.

• Perform upstream and downstream components of assigned cGMP project(s)

• Identify, document and report operating excursions and facility deficiencies; make recommendations for process improvements and documentation improvements including Standard Operating Procedures (SOP) and manufacturing Batch Records (BR).

• Contribute to detailed manufacturing budget; including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outlining overall and per/patient costs for project materials and supplies.

• Devise and revise methods and/or processes for SOP and Manufacturing Batch Records.

• Independently track, verify and ensure cGMP grade raw materials for biomanufacturing. Identify and plan for supply chain and raw materials lead times for scheduled campaigns.

• May prepare and submit abstracts or papers for publication in peer-reviewed journals and/or presentation at scientific conferences. Present results during internal meetings.

Minimum Education and Experience

Bachelor's degree in related scientific field or an equivalent combination of education and experience.

Knowledge, Skills and Abilities:

• Strong understanding of biological scientific principles

• Working experience with aseptic cell culture

• 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.

• Maintain knowledge of cGMP environment requirements.

About Us

At Stanford, every employee plays a part in our mission for a better tomorrow—from researchers to operations and from food services to educators. Join our team to work towards a future you believe in.

The job duties listed are typical examples of work performed by positions in this job classifications 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.

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 help ticket.

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. See Admin Guide 1.7.4: Equal Employment Opportunity, Non-Discrimination, and Affirmative Action Policy; Know Your Rights: Workplace Discrimination is Illegal.