Job Type Full-time 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 Assay Development Scientist in Gainesville, FL . This position is responsible for developing and performing 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 (Weekends and / or Holidays) as needed
Our Benefits
Generous Paid Time Off (PTO) planMedical, dental, and vision insurances available to full-time employees the first of the month after 60 daysSupplemental insurances including life, cancer, accident, and disabilityAccess to mental wellness resources and counseling through telehealthFree basic life insurance for full-time employeesHealth Savings Account (HSA) with employer match each pay periodEmployer funded retirement plan for vested employees & 403b offeredEmployee wellness programAccess to wages prior to pay dayShift differential for applicable evening and overnight hoursResponsibilities 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 cGMP (current Good Manufacturing Practice) manufacturing activities according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule.Coordinate and plan the preparation of cells and tissues for testing by flow cytometry or other analysis as needed.Maintain facility records, batch records, and process / system records as required throughout the manufacturing process according to Good Documentation Practice (GDP) standards.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.Troubleshoot and correct issues that may adversely affect test performance or reporting of test results, or immediately notify a supervisor, manager, or director.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 requiredOne year of pertinent laboratory experience requiredKnowledge of CMO / CDMO processes, cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturingScientific 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 federalKnowledge of state and federal laws, rules, and regulations and voluntary accrediting standards related to the operation of clinical laboratories and blood banksKnowledge of laboratory processes, inventory requirements, and quality systemsNational certification as a Medical Laboratory Scientist (ASCP or AMT) or Certified Advanced Biotherapies Professional (CABP) preferredHigher level education, such as master’s degree in relevant field, is preferred.Two to four years of relevant laboratory or quality experience with experience in cellular therapy testing or manufacturing, with development or optimization of testing or processes, preferredPrevious experience in cell or tissue culture preferredExperience working in a Research and Development environment is preferredThis position also requires applicants to have experience in, or an understanding of, the following :
Aseptic processing in ISO 5 biosafety cabinetsUniversal precautions for handling human derived materials in BSL-2 containment areasCell expansion using incubatorsCell washing processes and automated equipmentCell separation techniques and automated equipmentCryopreservation processes and equipmentWho Are We
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 $70,000 - $84,000 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).
