3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient's parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDA's requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In pre-clinical studies the platform has demonstrated the ability to generate functioning living tissues. JOB SUMMARY

The Quality Control Analyst assists in the development of Quality Control (QC) procedures, specifications, testing, and verification of clinical-grade products under a GMP laboratory setting/

RESPONSIBILITIES

• Develops and performs QC assays for manufactured products, including flow cytometry, cell counts viability, endotoxin, bioburden, ELISA, qPCR, colorimetric assays, and fluorometric assays.

• Experience with data review, authoring SOPS, CAPA, change controls, out-of-specification (OOS), investigations, and report writing is recommended.

• Undertakes activities to ensure corporate compliance with regulatory requirements as it relates to cGMP standards.

• Creates, maintains, and optimize SOPs and forms as needed.

• Maintenance of cGMP Equipment.

• Prepare and maintain detailed records and summary reports of all procedures and test results.

• Prepare Certificates of Analysis for manufactured products.

• Organize and present data at meetings when requested.

• Perform other job-related duties as required.

• Support establishment of and perform analytical testing of in-process, final product, and stability samples supporting drug product manufacturing.

• Utilize scientific principles to assist in analytical testing methods and the proper us of laboratory equipment

MINIMUM QUALIFICATIONS

• Bachelor's degree in the life sciences (chemistry, biology, biomedical engineering, or related field) is required.
• Minimum of 2-3 years of relevant laboratory experience in a regulated GMP environment.
• Excellent communication, presentation, and record-keeping skills.
• Able to work in a fast-paced and cross-functional environment.
• Extremely organized and self-managed.
• Comfortable with working traditional and non-traditional hours.

PREFERRED QUALIFICATIONS

• Prior experience in a QC role at a cGMP compliant biotech/pharma company is highly desired.
• Understanding of cell culture, cells and/or tissue sample analysis preferred.
• Aseptic technique, clean room environmental monitoring and clean room experience.