Cell Therapy Technical Specialist - Laboratory, Translational Area

Job Overview

Fairview is seeking a Medical Laboratory Scientist (MLS) to serve as a Cell Therapy Technical Specialist focused on our Translational Area. The Cell Therapy Laboratory is located on the University of Minnesota St. Paul Campus.

Our Laboratory specializes in cell and tissue manufacturing of hematopoietic stem cells (HSCs) and somatic cell therapies derived from bone marrow, peripheral blood, umbilical cord blood, and other tissues for reconstitution and somatic cellular treatments. In this role, the Technical Specialist will be responsible for the development, validation, and clinical production of novel cell therapies, serving as a key technical resource, problem solver, process improvement lead, and research liaison.

Key Responsibilities

• Translational Development & Clinical Production: Coordinate product development, validation plans, and assay development. Oversee QC testing (flow cytometry, bioburden, cell enumeration, viability, and potency), documentation (batch records/SOPs), vendor/equipment qualifications, project timelines, and training.
• Technical Resource: Provide guidance, training, and troubleshooting support to CT staff.
• Daily Workflow Management: Direct daily tasks, assign workloads, adjust schedules to meet demands, and provide input on performance appraisals.
• Data & Regulatory Quality: Ensure accurate and timely data entry; investigate deviations; and provide input on regulatory and project-specific reports.
• Equipment: Maintain and troubleshoot laboratory equipment, coordinate manufacturer services, and qualify new equipment.

Key Competencies

• Technical Expertise: Knowledge of cell therapy theories, methodologies, and instrumentation with strong critical-thinking skills. Adept at utilizing various computer systems and computer applications:  databases, Word, Excel, Access, etc.
• Communication & Leadership: Clear written/oral communication skills, promote teamwork internally and across departments, and support continual learning of self and coworkers.
• Problem Solving & Adaptability: Display project management abilities, stress tolerance, and a proactive approach to continuous process improvement.

Required Qualifications

• Baccalaureate or higher degree from an accredited college/university in a related laboratory field including the related lab practicum or equivalent routes meeting qualifications as either a general supervisor for high complexity testing or a technical consultant for moderate complexity testing (dependent upon specialty) as specified in CLIA ’88.
• Bachelor of Science from an accredited college/university in chemical, biological, clinical or medical laboratory science, or medical technology. (Diploma with field of study listed or transcript must be provided); or
• B.S./B.A. from an accredited college/university with 16 semester hours in biology including one semester in microbiology and 16 semester hours in chemistry including one semester in organic or biochemistry meeting qualifications as a general supervisor for high complexity testing as specified in CLIA ’88. (Transcript must be provided); or
• Combination Education & Experience including completion of a 50-week U.S. military medical laboratory training course and a Baccalaureate degree from an accredited college/university with 16 semester hours in biology including one semester in microbiology and 16 semester hours in chemistry including one semester in organic or biochemistry meeting qualifications as a general supervisor for high complexity testing as specified in CLIA ’88. (Transcript must be provided); or
• Master of Science from an accredited college/university in molecular biology, biotechnology, chemistry, biology, cytology, immunology, immunohematology, microbiology, allied health, medical laboratory science, or an appropriately related field meeting qualifications as a general supervisor for high complexity testing as specified in CLIA ’88. (Diploma with field of study listed or transcript must be provided)
• 1 year laboratory training or experience, or both, in high complexity testing required for candidates with baccalaureate or higher degree in chemical, biological, clinical or medical laboratory science, or medical technology when filling a CLIA General Supervisor role; or
• 1 year laboratory training or experience, or both, in moderate complexity testing required for candidates with baccalaureate or higher degree in chemical, biological, clinical or medical laboratory science, or medical technology when filling a CLIA Technical Consultant role; or
• 2 years laboratory training or experience, or both, in high complexity testing required for candidates qualifying by baccalaureate degree and semester hours.
• Applicant should possess or be eligible to receive appropriate Department of Health and Human Services (HHS) approved laboratory certification. • Labs-Acute Care – ◦ ASCP, ASCPi, or AMT – MLS or MT ◦ HEW Medical Technologist certification may be considered. • Labs-Admin – ◦ ASCP, ASCPi, or AMT – MLS or MT • Labs-Outreach – ◦ ASCP, ASCPi, or AMT – MLS or MT • Labs-Point of Care – ◦ ASCP, ASCPi, or AMT – MLS or MT • Labs-Electron Microscopy – ◦ ASCP or ASCPi – HTL • Labs-Blood Bank – ◦ ASCP or ASCPi – BB or SBB • Labs-Cytology – ◦ ASCP – CT or SCT • Labs-Cytogenetics – ◦ ASCP or ASCPi – MLS, MT, CG, MB, SH, or SMB ◦ AMT – MLS or MT • Labs-IFC – ◦ ASCP or ASCPi – MLS, MT, SCYM, or SH ◦ AMT – MLS or MT • Labs-Histology – ◦ ASCP – CT or HTL ◦ ASCPi – HTL • Labs-Immunology/HLA – ◦ ASCP or ASCPi – MLS or MT ◦ AMT – MLS or MT ◦ ACHI – CHT or CHS • Labs-Infectious Disease – ◦ ASCP or ASCPi – MLS, MT, M, SM, MB, SMB, V or SV ◦ AMT – MLS or MT • Labs-Molecular Diagnostics – ◦ ASCP or ASCPi – MLS, MT, MB, or SMB ◦ AMT – MDT, MLS or MT • Labs-Special Chemistry – ◦ ASCP or ASCPi – MLS, MT, C or SC ◦ AMT – MLS or MT * Lab - Andrology *ASCP - MLS *AAB - ALS (Andrology Laboratory Scientist within 1 Year

Preferred Qualifications

• 2 years experience in area of specialty or subspecialty.

Benefit Overview

Fairview offers a generous benefit package including but not limited to medical, dental, vision plans, life insurance, short-term and long-term disability insurance, PTO and Sick and Safe Time, tuition reimbursement, retirement, early access to earned wages, and more! Please follow this link foradditional information: https://www.fairview.org/careers/benefits/noncontract

Compensation Disclaimer

The posted pay range is for a 40-hour workweek (1.0 FTE). The actual rate of pay offered within this range may depend on several factors, such as FTE, skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization values pay equity and considers the internal equity of our team when making any offer. Hiring at the maximum of the range is not typical. If your role is eligible for a sign-on bonus, the bonus program that is approved and in place at the time of offer, is what will be honored.
EEO Statement

EEO/Vet/Disabled: All qualified applicants will receive consideration without regard to any lawfully protected status