Bioengineer

Company Description

BioXtek is committed to transforming healthcare by introducing a new biologic paradigm that enhances patient outcomes for a wide range of medical and surgical conditions. Our focus is on achieving superior results without side effects or adverse events, ensuring high levels of patient success. Located in Pompano Beach, FL, BioXtek specializes in producing high-quality, cGMP-cGTP-compliant products by utilizing human placental birth tissues as base materials. We deliver innovative solutions to advance the medical

Overview

We are seeking a highly motivated and results-oriented Bioengineer to join our team at a cutting-edge human tissue bank in Florida. The ideal candidate is a dynamic problem-solver who excels at driving complex projects from concept through to regulatory approval (510(k) or BLA). This role requires deep expertise in stem cell and exosome technologies, a robust understanding of cGTP/cGMP compliance under FDA, AATB, and AABB standards, and a proven ability to manage time-sensitive projects effectively.

Key Responsibilities

• Project Leadership & Execution:
• Lead and execute bioengineering projects focused on developing and optimizing processes for the recovery, processing, storage, and testing of human cells and tissues, with a specific focus on stem cells and exosomes.
• Demonstrate a commitment to timely project completion, actively avoiding "paralysis by analysis" and ensuring project milestones are met within defined time parameters.
• Proven ability to identify solutions, not obstacles, proactively addressing technical challenges and process bottlenecks.
• Technical & Laboratory Expertise:
• Perform and oversee advanced techniques for culturing, expanding, and cryopreserving stem cells.

·       Design, execute, and analyze associated testing methodologies for both stem cells and exosomes, including viability, potency, and characterization assays.

·       Maintain the highest level of sterility and aseptic technique within the cleanroom and laboratory environment.

• Regulatory & Quality Assurance:
• Possess a strong, working knowledge of FDA (e.g., 21 CFR 1271, cGMP), AATB (American Association of Tissue Banks), and AABB (formerly American Association of Blood Banks) quality standards and regulations.
• Author, review, and maintain critical quality documentation, including detailed Validation Plans, Process Records, Standard Operating Procedures (SOPs), and Batch Records.
• Participate in internal and external audits as a subject matter expert.
• Product Development & Commercialization:
• Lead the development pipeline, taking new tissue and cell-based products from initial concept through to submission and successful clearance/licensure (510(k) or Biologic License Application - BLA).
• Coordinate cross-functionally with Quality, Operations, and Clinical teams to ensure smooth technology transfer and scale-up.
• Communication & Interpersonal Skills:
• Act as a personable and professional representative of the department, fostering collaborative relationships with colleagues, vendors, and regulatory bodies.
• Clearly communicate complex technical and regulatory information to both technical and non-technical audiences.

Qualifications

• Education: Bachelor’s or Master’s degree in Bioengineering, Biomedical Engineering, Cell Biology, or a closely related scientific field.
• Experience: Minimum of 5 years of experience in a cGTP/cGMP regulated environment, preferably in the human tissue, cell therapy, or biologics industry.
• Skills:
• Demonstrated history of successful project management, evidenced by moving at least one project from concept to a fully approved 510(k) or Biologic License (BLA).
• Expertise in primary stem cell culture techniques.
• Familiarity with methods of exosome isolation and characterization.
• Exceptional technical writing skills for regulatory and quality documentation.