Lead QC Scientist, HGCTF - Dean's Office

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

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)