Job Title: Scientist I

Work Location: Bexar County, Texas

Summary:

Seeking a Scientist I to provide expertise in cellular therapy and regenerative medicine assay development, focusing on testing for viability, purity, potency, safety, and cell characterization. This role involves managing and coordinating scientific activities related to product testing, including new product development, qualification, validation, technical transfer, and laboratory personnel training.

Responsibilities:

• Lead the implementation and continuous improvement of cellular therapy and regenerative medicine product assays, utilizing methodologies such as flow cytometry, PCR, ELISA, bioassay, and potency assays.
• Collaborate with cross-functional teams and provide leadership on projects related to cellular therapy assay development.
• Establish and maintain relationships with internal teams, clients, suppliers, partners, and regulatory agencies.
• Guide and participate in strategic initiatives, including the development and execution of project plans and budgets.
• Independently design, execute, and interpret laboratory experiments and validation studies for process and method evaluation.
• Author SOPs, support training and competency assessments, participate in audits, and serve as a departmental liaison as needed.
• Set operating parameters and quality control limits, and assist in resolving technical issues and quality improvement investigations.
• Maintain accurate records, ensure adherence to SOPs, and perform data entry and reporting as required.

Qualifications:

• Master’s Degree in Cellular Biology, Molecular Biology, Biochemistry, Cellular Engineering, or a closely related field from an accredited institution; Ph.D. preferred.
• Five or more years of experience in regenerative medicine or cellular therapy testing, ideally in a cGMP, FDA-regulated, or clinical laboratory environment.
• Technical expertise in aseptic technique, mammalian cell culture, flow cytometry, qPCR, multiplex ELISA, bioassay, potency assay, and microscopy.
• Valid United States Driver’s License required; US Passport and relevant professional certifications preferred.

Published Category: Analytical & Process Development