Description Under the supervision of the Manufacturing Manager of the Center for Advanced Biotherapies (CAB), the CAB Lead Manufacturing Scientist is responsible for the manufacturing of human gene and cell therapy products under Good Manufacturing Practices (GMP), quality control testing of these products to ensure that the products meet the required quality, oversee other manufacturing associates and overall management of all projects.
The purpose of the CAB is to manufacture clinical grade gene and cellular therapy products for novel patient treatments in clinical trials, and to perform scholarly research and development when appropriate. These objectives are to be met within the limits of resources available with an emphasis on cost effectiveness and innovation. The Lead Manufacturing Scientist must have advanced tissue culture expertise, preferably including human cell line and stem cell culture.
This position requires experience with GMP-grade culture and formulation of various human cell types, including peripheral blood mononuclear cells (PBMCs), T cells, dendritic cells, mesenchymal stromal cells, human embryonic stem cells, and induced pluripotent stem cells. In addition, the candidate must possess strong project and personnel management skills and have experience conducting and managing quality control testing.
Annual Salary Range: $90,720.00 - $194,040.00 Qualifications Required: Bachelor of Science or Master of Science or Ph. D. Degree in Biology, Chemistry, or related field and a minimum of 2 years of manufacturing experience in GMP setting.
Knowledge and practical experience in aseptic technique/tissue culture. Understanding of GMP requirements and regulations. Previous experience directly involved with federal regulations regarding GLP and GMP.
Knowledge of Standard Operating Procedures and Quality Control requirements in a GMP laboratory setting. Work independently, with emphasis on the ability to closely follow SOPs. Ability to wear protective clothing for extended periods of time including: gowns, coveralls, gloves, masks, face shields, goggles, sleeves and head covers.
Ability to work flexible hours, various hours on short notice (including covering staff shortages and holiday shifts); determine workload priorities for completion of job assignments in a timely manner to meet critical deadlines Ability to serve as a resource for complex procedure or equipment troubleshooting in areas of expertise, and/or solicits same as necessary in areas where expertise is deficient. Work under regular exposure to zoonotic diseases, anesthetic agents, and cleaning chemicals.
Strong interpersonal communication skills to effectively and diplomatically interact with physicians, staff, administration & sponsors. Experience managing complex projects is required as well Advanced knowledge of cell culture, cell line development, bioreactor operation and scale-up, centrifugation and ultracentrifugation, tangential flow and normal flow filtration Expert in flow cytometry, protein, mRNA, DNA characterization 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 ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions. 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 accruacy to ensure that incorrect/incomplete data is corrected. Ability to deal with and maintain confidential and sensitive information with discretion. 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.
Ability to work on a diverse variety of projects simultaneously, organize multiple projects for efficiency and cost-effectiveness. Demonstrated skill in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work. Ability to attend off-site staff meetings, conferences and investigator meetings.
Ability to write concise and accurate administrative reports, policies, procedures, and correspondence. Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel. Demonstrated skill in records management.
Skill in establishing and maintaining complex filing systems. Demonstrated skills with personal computers, spreadsheets, databases and word processing applications for the maintenance of records, analysis of data, and the preparation of reports.