Cellular Therapy Scientist

Description

Are you looking to make a difference in your community?

LifeSouth Community Blood Centers is looking for an individual to join our team as a Cellular Therapy Scientist in Gainesville, FL. This position is responsible for performing and developing testing, processes, troubleshooting, and investigation related to cellular therapy and manufactured biologics. Duties and projects may relate to products intended for research, commercial, and clinical use.

• Must have the ability to work variable shifts (Days, Nights, Weekends and/or Holidays) as needed**
  
  

Our Benefits

• Generous Paid Time Off (PTO) plan
• Medical, dental, and vision insurances available to full-time employees the first of the month after 60 days
• Supplemental insurances including life, cancer, accident, and disability
• Access to mental wellness resources and counseling through telehealth
• Free basic life insurance for full-time employees
• Health Savings Account (HSA) with employer match each pay period
• Employer funded retirement plan for vested employees & 403b offered
• Employee wellness program
• Access to wages prior to pay day
  
  

Responsibilities Include (but Are Not Limited To)

• Collaborate closely with the Cellular Therapy and Laboratory departments to develop and optimize procedures related to cellular therapy product production and testing
• Assist with development and performance of basic manufacturing activities and operating equipment
• Perform isolation and purification of cells and cellular components from tissues and blood
• Coordinate and plan the preparation of cells and tissues for testing by flow cytometry or other analysis as needed
• Meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to Good Documentation Practice (GDP) standards
• Ensure finished substance/ product and all intermediates follow applicable regulatory requirements (e.g. FDA, cGMPs, cGTPs), Through strict adherence to manufacturing controls
• Adhere to all policies, document all quality control activities, and ensure that instrument and procedural calibrations and maintenance is performed in accordance with approval policies and procedures
• Identify problems that may adversely affect test performance or reporting of test results
• Document all corrective action taken when test systems deviate from the laboratory’s established performance specifications
• Participate in packaging and presentation of data in both written and/or oral formats (such as peer-reviewed publications and regional/national conferences)
• Exercise professional judgment in evaluation, specimen integrity, results accuracy, and inter-result validity and take corrective action as necessary. Such corrective action can include, but is not limited to: specimen rejection, recollection, and/or retesting using the same or alternate methods and/or utilizing other skills to ensure validity and accuracy of testing at all times
  
  

Minimum Qualifications

• Bachelor’s degree in Clinical Laboratory, Chemical or Biological Science
• One year of laboratory experience
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Technical writing capability
• Experience or understanding of the following areas is required: Aseptic processing in ISO 5 biosafety cabinets, Universal precautions for handling human derived materials in BSL-2 containment areas, Cell expansion using incubators, Cell washing processes and automated equipment, Cell separation techniques and automated equipment, Cryopreservation processes and equipment
• Understanding of cell/tissue culture techniques including media production selection/isolation, activation/initiation, transduction, de-bead (if applicable), expansion, harvest, and cryopreservation
• Scientific and technical knowledge from current sources, such as the AABB/FACT/NETCORD Standards and relevant guidance related to FDA, CLIA, and CMA, both state and federal
• Knowledge of state and federal laws, rules, and regulations and voluntary accrediting standards related to the operation of clinical laboratories and blood banks
• Knowledge of laboratory processes, inventory requirements, and quality systems
  
  

The Ideal Candidate Will Possess

• Master’s Degree
• National certification such as MLS (ASCP or AMT) or CABP from AABB
• Two to four years of lab experience in cellular testing
• Experience in cell or tissue culture
  
  

Who We Are

LifeSouth is a non-profit community blood bank serving more than 150 hospitals in Alabama, Florida, Georgia and Tennessee. We are committed to meeting the blood supply needs of hospitals and their patients by providing the highest quality blood components and services. With more than 45 donor centers, 55 bloodmobiles and 2,000 blood drives a month, our LifeSouth team is dedicated to making sure the blood is there when you or your family is in need.

Our Mission

To provide a safe blood supply that meets or exceeds the needs in each community we serve, and to provide a variety of services in support of ongoing and emerging blood and transfusion related activities.

This is a full-time position. Starting salary range is $65,000.00 - $71,500.00 per year. Criminal background check and drug screen required upon conditional offer of hire. Equal Opportunity/Affirmative Action Employer/Drug-Free/Tobacco Free Workplace.

The position description may not include all the duties and responsibilities of the job. Duties and responsibilities that are not listed, but which the employee may be expected to perform, will fall within the scope of the skills, knowledge and training for the position.

LifeSouth is a Drug-Free and Tobacco-Free Workplace. LifeSouth is a VEVRAA Federal Contractor as well as an affirmative action employer and provides equal opportunity to all persons, regardless of race, religion, age, gender, disability, status as a protected veteran, national origin, color, or any other classification in accordance with federal, state, and local statutes, regulations and ordinances. Veterans are encouraged to self-identify as LifeSouth desires to provide protected veterans priority referrals for open positions. LifeSouth complies with all laws and regulations associated with the Family Medical Leave Act (FMLA).

If you require any assistance to complete the application process or during the interview due to a disability, please contact the LifeSouth region where you are applying or call 1-888-795-2707 to request an accommodation. Applications may be completed at a LifeSouth facility or mailed to corporate headquarters in lieu of the on-line application process.