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)