Location: Memphis
Company: St. Jude Children's Research Hospital
scale-up in one or more of the following areas: gene therapy vectors, Monoclonal Antibodies, small molecules (i. e. peptides, cytokines), recombinant proteins, or bacterial/viral/DNA vaccines. The position is responsible for the proper conduct of specific projects, collection and analysis of data.
Check out the Experimental Cellular Therapeutics Laboratory (ECTL) here. The job responsibilities include but are not limited to: -Lead the development of manufacturing processes that meet c GMP requirements for cellular therapeutic products: Develops product characterization assays. Gains and routinely updates knowledge related to projects. Maintains proficiency in required laboratory skills
and actively pursue training in new laboratory skills or techniques. Develops or adopts new technologies as needed. -Manufactures cellular therapeutics under c GMP regulations: Effectively collaborates with Human Application Lab, Children's GMP, Clinical team, Quality Assurance and Vector Lab to manufacture cellular therapeutics for clinical trials.
Learns and applies c GMP requirements for manufacturing cellular therapeutics. Follows standard operating procedures, batch manufacturing records, and other relevant documents. Works with extreme attention to detail in a highly regulated environment. -Works with Quality Assurance to ensure compliance of all production activities with: c GMP
regulations Code of Federal Regulations Title 21(21 CFR) part 210 and 211 Current good tissue practice (c GTP) regulations (21 CFR part 1271) EMA (European Medicines Agency) ICH (The International Council for Harmonization of Technical Requirements for medicals for Human Use) Foundation for the Accreditation of Cellular Therapies (FACT) -Maintains accurate and detailed documentation: Maintains electronic laboratory notebook and paper notebook system to document all laboratory activities.
Always keeps accurate dated records. Reports deviations to procedure promptly. -Trains personnel in procedures and techniques of the laboratory: Facilitates orientation of new personnel to the laboratory.
Instruct new staff on use of laboratory equipment. Demonstrates specific standard operating procedures as required. Participates in continuing education. Stays abreast of current techniques by attending seminars, reading articles, attending training sessions and meetings. Exhibits proper knowledge and execution of safety procedures. -Clearly communicates with stakeholders and represents ECTL to present results in various formats and occasions. -Maintains regular and predictable attendance and requires occasional weekend hours as needed. -Performs other related duties as assigned in order to meet the goals of the department and institution.
Minimum Education and/or Training: Bachelor's Degree Required in relevant scientific area. Master's Degree/Ph D Preferred. Minimum Experience: Minimum Requirement: Bachelor's degree with 7+ years experience in relevant scientific area (e. g. GMP: chemistry, biology, chemical engineering, analytical chemistry, biotechnology; ECTL: cellular biology, molecular biology, immunology, biochemistry). Experience exception: 5+ years of experience in relevant area with Master's Experience exception: 3+ years of experience in relevant area with Ph D Prior experience in relevant area to own domain (e.
g. upstream/downstream c GMP experience, process development, HPLC/biological assays) strongly preferred. Experience in lab and scientific project coordination, maintenance, and other research support activities preferred. St Jude Employees receive: Excellent healthcare plans with zero to low health premium costs Onsite health clinic, shop, and exercise facilities Paid parental leave and adoption assistance Immigration Services Tuition Reimbursement St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion.
Our founder Danny Thomas envisioned a hospital that would treat children of the world-regardless of race, religion or a family's ability to pay. Learn more about our history and commitment. Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St.
Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future. Other Information St. Jude is an Equal Opportunity Employer No Search Firms St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St.
Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
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