Requires knowledge and experience in the fields of medical and biological sciences; still acquiring higher-level knowledge and skills. One of the key roles will entail performing hands-on cellular manipulation procedures in a clean room (ISO7) environment following strict standard operating procedures (SOPs). Customer service skills are essential for this position in order to serve multiple investigators driven clinical trials. Solves a range of straightforward problems. Analyzes possible solutions using standard procedures. Receives a moderate level of guidance and direction.
Cellular Processing and Manufacturing: 70%
Perform a variety of cellular product processing procedures under Gâ™Xâ™P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.
Perform a variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy.
Perform a variety of special manufacturing projects under cGMP guidelines as directed with speed and accuracy.
Provide backup support to a variety of cellular product projects to the Advanced Cellular Therapeutics Facility.
Transport prepared vaccines/cell therapy products to the clinic or pharmacy.
Quality Control: 15%
Perform various assays including but not limited to CAP proficiency and competency assays as needed for Cell Therapy processes.
Perform various assays as needed for Cell Therapy processes to standard best practices.
Perform various standard operating procedures as need for facility operations.
Assist in the set up new lab equipment used in Quality Control Laboratory and assist with upkeep such as setup, temperature monitoring, daily verification with QC, instrument/operation/performance qualifications (IQ/OQ/PQ), routine maintenance, troubleshooting.
Support cGMP compliance through validation and qualification of processes, material and supplies, equipment and facility processes, perform vendor qualification of manufacturing supplies and material.
Ensure all materials and samples are stored correctly at the right temperatures.
Facility Operations: 15%
Help monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.
Assist in instrumentation error reports and deviations.
Perform room change-over in facility after campaigns with specialized cleaning to maintain GMP fashion.
Attend all required training and comply with all safety and operations procedures.
Perform all other duties as requested by the Technical Director or QA/QC Manager.
Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.
Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
Provides technical and administrative support for a research project.
Assists with the installation, sets up and performs experiments; interacting with students and other laboratory staff under the direction of the principal investigator
Performs other related work as needed.
Working knowledge of Gâ™Xâ™P.
Working knowledge of CLIA and CAP.
Ability to work in a cGMP sterile clean room setting in required.
Excellent customer/staff interpersonal skills.
Ability to read and write and follow documents including protocol and SOPs.
Capacity to handle multiple tasks and competing demands under tight timeframes.
Execute and lead operation to comply with all oral and written procedures including Batch Records and SOPs.
Attention to detail.
Ability to demonstrate excellent interpersonal and communication skills; required.
Strong emphasis on documentation according to FDA regulations and other regulating bodies.
Excellent verbal and written communication skills.
Capacity to exhibit organizational skills; required.
Ability to work in a collaborative team environment.
Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment.
Ability to understand, retain, and carry out instructions and solve problems in complex situations.
Ability to independently learn new techniques.
Ability to interact with all levels of staff in a professional manner while respecting patient confidentiality.
Excellent customer/staff interpersonal skills.
Education, Experience or Certifications:
Bachelor's degree in biology, medical laboratory science, medical technology, molecular/bio-engineering, or closely related field required.
Advanced degree preferred
A minimum of 2 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field required.
A related masterâ™s degree is preferred that may offset required years of experience at 1:1 (i.e. a two-year masterâ™s degree in lieu of two years of experience).
Prior experience in cell culture, analytical assay performance and development, viral gene transduction, and sterile filling techniques preferred.
Technical Knowledge or Skills:
Advanced skills with Microsoft Office Suite.
Working Conditions and Physical Requirements:
Must be detail-oriented, well organized and approach procedures with critical thinking of the technical aspects with strong communication skills and ability to work in an interactive team environment.
Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills.
Ability to perform light/medium work, which includes lifting up to 30 pounds.
Occasionally must bend, twist, squat, climb, reach, stoop, and kneel.
Ability to be mobile walking from building to building.
Ability to sit for some period of up to 2 hours.
All employees within this job classification may have exposure to blood-borne pathogens, other potentially infectious materials, and/or hazardous chemical waste.
Cover Letter (preferred)
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