QC Potency Analyst III

About Bora:

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from Firstin Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose built for commercialization. Our inspectionproven, bicoastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

This position is responsible for performing activities to support analytical testing programs at Bora Biologics to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will guide and partner with lower level QC analysts to provide feedback and technical information. This individual will also ensure accurate documentation, timely completion of all analytical related testing, and timely review of data, while adhering to standard operating procedures and cGMPs.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Performs routine analytical testing including complex methods such as ELISA, bioassays, and Cell Culture as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality, for in process, product release, and stability samples on a daily basis in accordance with all protocols and procedures. Enters data into Laboratory Information Management System (LIMS).
• Performs peer review of test data generated by other analysts to identify discrepancies and out of range results and to ensure adherence to standard operating procedures and GMPs. Identifies analytical data trends and reports findings and provides recommendation to supervisors for review and consideration.
• Conducts investigation when there are out of specification results from testing and reports to supervisor.
• Initiates and monitors progress of analytical related Quality event records(e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.
• Develops, revises, and updates standard operating procedures, as needed.
• Collaborates with Senior QC team members to participate in the development, transfer, and validation of analytical testing methods and conducts training on analytical test methods to other QC Analysts as needed.
• Overseas lab equipment calibration and maintenance processes as required for testing per standard operating procedures, and raises any concerns about equipment to supervisor for resolution.
• Participates in troubleshooting of analytical test methods and instruments, as needed.
• Performs special projects related to problems encountered with analytical testing and instruments, and makes recommendations for solutions that will minimize future issues.
• Mentors and trains lower lever analysts, as needed.
• Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.

Education
:
Minimal formal education required ( Bachelor's Degree)

Experience
:
Minimum number of 4 years of experience is required

Knowledge
: GMP: potency and residual testings and/or GLP ELISA, Bioassay, Quality Control.

Skills/Abilities: Working knowledge of good laboratory practices.

* Excellent understanding of GMPsrelated to the biotech or pharmaceutical industry

* Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced

environment.

* Ability to work on extremely complex problems in which analysis of situation or data requires an in-depth

evaluation of intangible variables.

*…