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Under the supervision of the QC Manager of the Human Gene
and Cell Therapy Facility (HGCTF), the HGCTF Lead QC Scientist is responsible
for the daily operation of the QC laboratory to ensure it is in control and in
compliance with applicable regulations. The Lead QC Scientist will oversee
compendial and non-compendial methods for test of products
manufactured/prepared at the HGCTF. The Lead QC Scientist will lead and perform
analytical testing of starting materials, in-process samples, release testing of
drug substance and drug products. The Lead QC Scientist will lead and oversee
technology transfer, method development, qualification/validation and/or
verification of test methods as per applicable regulatory guidelines
This position will be responsible for leading different QC
projects and troubleshooting, analyzing data and generating reports. This
position requires a high level of confidentiality and discretion to achieve the
goals as emphasized by leadership.
Salary Range: $86,400 - $184,800 Annually
Qualifications
Required:
Bachelor of Science degree, or Master's degree in Biology,
Chemistry, or related field and a minimum of five years of GMP assay
development or quality control experience, a higher degree (Ph.D or Pharm D.)
with knowledge about GMP QC or an equivalent combination of education and
experience.
Demonstrated knowledge and experience in excellent tissue
culture skills (human cell line and stem cell culture preferred) to be trained
in GMP grade culture of continuous human cell lines, multi potent stem cells
such as mesenchymal stromal cells (MSC), hematopoietic stem cells (HSCs) and
pluripotent stem cells, such as human embryonic stem cells (hESCs) and induced
pluripotent stem cells (iPSCs).
Advanced knowledge of the following analytical
methods/equipment: cell counting and viability using trypan blue,
nucleocounter, multi-color flow cytometry, PCR, ddPCR and other cellular
assays.
Advanced knowledge of quantitative and qualitative
analytical methods design utilizing the equipment listed above.
Familiar with data analysis with large data set, as well as
data visualization software is a plus.
Experience with qualification, technology and method
transfer, and validation/verification of analytical methods.
Experience with compendial testing for Cell and Gene
Therapy, including endotoxin and mycoplasma. Experience with environmental
monitoring is a plus.
Experience with people management and/or project
management.
Familiarity with Good Manufacturing Practices (GMP)
regulations.
Knowledge of Standard Operating Procedures and Quality
Control requirements in a GMP laboratory setting.
Knowledge of proper product documentation and labeling at a
GMP level.
Communication skills required to coordinate and verify
results, monitor for completeness and accuracy required.
Ability to work flexible hours, various hours on short
notice (including covering staff shortages, weekends and holidays); determine
workload priorities for completion of job assignments in a timely manner to
meet critical deadlines.
Ability to serve as a support for complex procedure or
equipment troubleshooting in areas of expertise, and/or solicits same as
necessary in areas where expertise is deficient.
Excellent English-writing skills to compose, proofread
correspondence and written reports for conciseness, clarity, appropriate
grammar, correct spelling and proper punctuation.
Ability to write concise and accurate administrative
reports, polices, procedures and correspondence.
Excellent record keeping skills and good documentation
practices.
Demonstrated ability to work independently and
collaboratively with multiple departments while utilizing innovation to elicit
compliance.
Demonstrated skill in gathering pertinent data, preparing
narrative reports, statistical reports, charts, graphs and tables.
Demonstrated skill in reviewing documents, data and
material compiled by others for completeness and accuracy to ensure that
incorrect/incomplete data is corrected.
Ability to deal with and maintain confidential and
sensitive information with discretion.
Ability to determine what information is confidential and
to protect the confidentiality of that information.
Demonstrated skill in good decision making and taking
appropriate action in situations where no established criteria exists or where
answers to problems are not readily available.
Demonstrated skill in prioritizing workflow to meet
deadlines, often under pressure of conflicting demands, while maintaining
accuracy and effectiveness of work.
Working knowledge of some medical and scientific
terminology for protocol abstracting and conversation with research personnel.
Demonstrated skill in records management. Skill in
maintaining complex filing systems.
Demonstrated skills with personal computers, spreadsheets,
databases and word processing applications for maintenance of records, analysis
of data, and the preparation of reports. Exceptional computing skills. Ability
to learn other systems/software as required.
Preferred:
2+ years of aseptic cell culture (human primary cells
and/or human cell lines)
At UCLA Health, you can help heal humankind, one patient at a time by improving health, alleviating suffering and delivering acts of kindness. As you do, you’ll achieve great things in your life and your career. We’re a world-class health organization with four hospitals consistently recognized among the nation’s very best as well as an internationally-renowned medical school, primary and specialty care clinics and much more. Within our dynamic, innovative and growing organization, you’ll find exceptional opportunities to make the most of your abilities in a supportive, empowering and inclusive environment. If you embrace our values of Integrity, Compassion, Respect, Teamwork, Excellence and Discovery we invite you to see all you can accomplish at UCLA Health.