Clinical Process Development & Manufacturing Professional 1

Stanford University; Palo Alto (CA); On-site; USD 85,000 - 130,000; Full time

Job summary

Stanford University’s Laboratory for Cell & Gene Medicine (LCGM) seeks a Clinical Process Development & Manufacturing Professional I focused on clinical viral vector products. The role involves planning and executing viral vector biomanufacturing campaigns and contributing to process development and tech transfer for clinical materials.

You will operate in a cGMP clean room, manage raw materials and documentation, and collaborate with cross-functional teams to deliver products for Phase I/II

Qualifications

• Bachelor's degree in related scientific field or equivalent combination of education and experience.
• Strong understanding of biological principles.
• Experience with aseptic cell culture.
• Familiarity with viral vector production, molecular biology, upstream and downstream processing preferred
• cGMP experience preferred

Responsibilities

• Plan, prepare for and perform viral vector manufacturing campaigns.
• Assist with process development and technology transfer for clinical materials.
• Maintain lab stock, safety records and general lab support.
• Identify and report excursions and deficiencies; propose SOPs and BR improvements.
• Verify cGMP grade raw materials and manage supply chain lead times.
• Prepare activities for cGMP manufacturing projects.

Skills

Aseptic cell culture

Biological principles

Computer skills

Work under deadlines

Communication skills

Organizational skills

cGMP knowledge

Education

Bachelor's degree in related scientific field

Job description

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

Core Duties:

• Plan, prepare for and perform human clinical materialsbiomanufacturing campaigns typically as a verifier. Prepare finalformed cellular products for clinical trials within productiontimelines and manufacturing schedules.
• Plan and perform components of process development and technologytransfer for manufacturing of clinical materials, scale-up/scale-out andoptimization activities in transitioning and translating pre-clinical,benchtop research into phase appropriate clinical trials.
• Perform upstream and downstream components of assigned cGMPproject(s)
• Identify, document and report operating excursions and facilitydeficiencies; make recommendations for process improvements anddocumentation 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 formanufacturing; outlining overall and per/patient costs for projectmaterials and supplies.
• Devise and revise methods and/or processes for SOP andManufacturing Batch Records.
• Independently track, verify and ensure cGMP grade raw materialsfor biomanufacturing. Identify and plan for supply chain and rawmaterials lead times for scheduled campaigns.
• May prepare and submit abstracts or papers for publication inpeer-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 equivalentcombination 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 mastercomputer programs, databases and scientific applications
• Ability to work under deadlines with minimal supervision
• Ability to maintain relationships and communicateeffectively
• Excellent organizational skills and demonstrated ability tocomplete detailed work.
• Maintain knowledge of cGMP environment requirements.