Senior Manufacturing Specialist
The Blood and Marrow Treatment Cell Therapy Facility (BMT CTF) at Stanford University is seeking a Senior Manufacturing Specialist. The BMT CTF is a multi-product 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 clinical trials and standard of care therapies.
This Senior Manufacturing Specialist will perform cell therapy processing, typically as an operator, for a variety of cell therapies in cancer immunotherapy and stem cell regenerative medicine to support Investigational New Drug (IND) Phase I trials. This role works both independently and collaboratively across the different functional teams: Process Development & Manufacturing, Regulatory Affairs, Quality Systems, Operations and Finance & Administration. Opportunities for Process Development will be available to incumbents in this position based on operational needs and current projects.
This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.
BMT CTF 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!
- Perform complex manufacturing processes
- Maintain detailed records using Good Documentation Practices (GDP)
- Analyze and evaluate results, and generate and evaluate clinical reports.
- Perform verification and review of cell therapy processing, test preparation, testing results, and reports generated by staff. Sign out reports to next level review or to physicians.
- Serve as expert, technical resource, and/or point person for one or more specialized areas or instruments in the department. Train and mentor other CTF Scientists.
- Evaluate, validate, and optimize new assays and/or cell therapy processes; may evaluate new technologies and make recommendations on new acquisitions and/or upgrades of instrumentation and software.
- Review quality assurance and quality control data and take corrective action for assigned area, as needed. Maintain documentation and assure that regulatory requirements are met.
- Assist with scheduling and workflow coordination.
- Write, review, and edit protocols and procedures; maintain procedure manuals
- Oversee completion of equipment maintenance, instrumentation calibration, quality control and documentation, and ensure adequate supply of supplies and equipment.
* - Other duties may also be assigned
- Bachelor's degree in biology, chemistry, microbiology, or other related field of study
- Experience in a cGMP regulated environment using controlled documents is preferred
- Experience in mammalian cell culture and/or Aseptic technique is preferred
- Experience in flow cytometry preferred
EDUCATION & EXPERIENCE (REQUIRED):
- Four year college degree in medical technology, life science or relevant field of study and five years of relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Advanced knowledge of all aspects of clinical sample testing in specific area(s) of expertise.
- Advanced understanding of complex testing processes and underlying biology of the system.
- Ability to independently interpret and synthesize results, from a wide variety of tests, correctly and quickly; and involve others at the appropriate time; may issue reports.
- Advanced knowledge of laboratory information system/database and operation, or ability to learn system quickly.
- Excellent oral and written communication skills in English.
- Ability to work under deadlines with general guidance is essential.
- Excellent organizational skills and demonstrated ability to accurately complete detailed work
- Possess full color vision.
- Constantly lift/carry/push/pull objects that weigh up to 10 pounds.
- Frequently stand/walk, use a computer, sitting, and grasp lightly/fine manipulation.
- Occasionally writing by hand, sort/file paperwork or parts, operate a manual pipette, operate foot and/or hand controls.
- Rarely kneel/crawl, climb (ladders, or scaffolds), twist/bend/stoop/squat, reach/work above shoulders, grasp forcefully, use a telephone, scrub/sweep/mop/chop/mix, lift/carry/push/pull objects that weigh 11-40 pounds.
- Position may require repetitive motion.
* - 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.
Additional PHYSICAL REQUIREMENTS:
- Work in ISO-8 clean room for multiple hours depending on needs and demands of project and product being manufactured
- High pressure, busy, often crowded environment.
- Work under extreme time constraints.
- Required to work with human blood and specimens; potential exists for exposure to blood borne pathogens by splash or spill.
- Required to work with radiation or electromagnetic fields, lasers and allergens/chemicals.
- May be "on call' or work occasional extended hours based on research requirements and business needs.
Additional WORKING CONDITIONS:
- May work with viruses and viral vectors: for example, lentiviruses, adeno-associated viruses, retroviruses
- May work with human embryonic stem cells (hESCs)
- Complete Training for working in manufacturing clean rooms
- May work long hours during manufacturing and product release (which may include weekend work for manufacturing and product release); required to stay until product is released
- Complete all required training for the facility and for each project related to safety, quality, regulatory and operations
- Follows Federal Drug Administration (FDA) regulations and current good manufacturing practices (cGMP).
- 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 based 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.