Quality Control Associate
: Job Details :

Who are we?

We are a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions. Our lead investigational product is Lomecel-B™, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging. Our mission is to advance Lomecel-B™ and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Our current headquarters and state of the art GMP manufacturing facility in Miami, FL consists of eight ISO 7 cleanrooms and ancillary areas as well as dedicated process development, quality control and warehousing space. We have and will continue to devote significant resources to process development and manufacturing to optimize process robustness and success rates in developing Lomecel-B and other potential product candidates. We are currently looking for a dedicated and passionate individual to join the team as Quality Control Associate. The incumbent will be responsible for conducting various biological tests and analyses to ensure investigational product quality and reproducibility.

Primary Responsibilities

• Prepare experimental materials using Standard Operating Procedures, Good Laboratory Practice and safety guidelines.
• Maintain accurate records of procedures, experiments, and equipment use.
• Experience drafting technical SOPs, working knowledge of design control.
• Perform quantitative experiments and analyses for multiple clinical research protocols.
• Assist with design, performing, analysis and interpretation of experiments as assigned.
• Support manufacturing and process development staff as needed.
• Serve as contact point as required.
• Adhere to work hours as needed to complete required tasks (may be required to work after hours and/or weekends as needed as part of stipulated salary);
• Strong attention to detail.
• Perform other related duties as assigned or requested.

Minimum Education/Experience

• Bachelors and/or Masters of Science in Biology, Biochemistry, or related field with commensurate experience.
• Minimum of 2 years laboratory bench experience.
• Industry experience, desirable.

General Requirements

• Excellent interpersonal/human relations skills; ability to work collaboratively in a fast-paced team environment.
• Excellent written and verbal communication skills.

Technical Skills/Expertise

• Solid understanding of and ability to perform molecular biology techniques such as ELISA, PCR, mammalian cell culture, etc.
• Experience performing Flow Cytometry analysis of cell samples.
• Familiarity with Flow Cytometry data analysis using FlowJo software preferable.
• Knowledge of cGMP/GLP/GDP regulations and experience working in cleanrooms.
• Experience in micro testing is beneficial.