"Quality Control Associate Scientist (QC2)"

Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Associate Scientist (QC2). This position will participate and/or may lead a specific analytical development project in collaboration with research teams and other cross-functional teams to evaluate, develop and design Quality Control assays, including complex chemical, biochemical, biological and/or microbiological testing. The role will be responsible for supporting/leading testing samples, generating SOPs compliant with GMP standards, assay qualification and training for assay technological transfer, and support testing for clinical manufacturing product release.

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:

• Perform increasingly complex chemical, biochemical, biological and/or microbiological testing, assays and procedures related to quality control (QC), including flow cytometry, qPCR, ddPCR, potency assays, endotoxin, mycoplasma, cell count and viability.
• Perform tests related to assays; collect, interpret, analyze and report data related to test results including investigation of out-of-specification and/or non-conforming test results.
• Lead and perform assay development, optimization, qualification, verification and validation.
• Document QC related test methods, Standard Operating Procedures (SOPs), and instructions to ensure consistency with cGMP and documentation practices.
• Manage supplies related to clinical materials manufacturing. Create selection criteria, justification and qualification of raw materials. Responsible for examining and documenting materials used in clinical materials manufacturing, consistent with defined, relevant quality standards and cGMP.
• Perform complex analysis, monitor and trouble-shoot pertinent equipment (e.g., flow cytometers, hematologic analyzers).
• Investigate out-of-specification and/or non-conforming test results. Initiate, investigate as appropriate, and prepare deviation reports for SOPs and test methods with input from supervisor in order to implement prevention or corrective actions.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Ability to effectively work in fast-paced environment with cross functional groups involved in multiple projects and timelines.
• Flexibility to support changing priorities.
• 3-5 years industry experience, preferably in GMP/GLP settings.
• Experience in Flow Cytometry, cell culture, qPCR, ddPCR. Experience in assay design and optimization is preferred.

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):

• Applicable or related experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
• Strong technical skills and experience with testing QC methods and concepts.
• Good understanding of cGMP or International Organization for Standardization (ISO) requirements, quality systems.
• Strong team-oriented, interpersonal skills and collaborative work style.
• Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
• Excellent organizational skills and attention to detail.
• Excellent verbal and written communication skills.

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 the job.

WORKING CONDITIONS:

• 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.
• 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, confined spaces, working at heights
• May require extended or unusual work hours based on research requirements and business needs.

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. The pay range for this position working in the California Bay area is $93,200.00 to $116,142.00 annually.