QC Analyst II - Analytical Potency

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 inspection proven, 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 USA, LLC. to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will be required to complete the testing and related documentation in a timely manner while adhering to standard operating procedures and under cGMPs.

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

• Performs routine analytical testing including more complex methods such as ELISA, Bioassays, and Cell Culture, as well as basic methods such as concentration by UV absorbance, pH, process residuals (e.g. Host Cell Protein, Protein A and PS80) using ELISA kits, for product release, and stability samples 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 ensure data integrity and adherence to standard operating procedures and GMPs.
• Reports out-of-specification results from testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.
• Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor.
• Prepares general lab reagents and buffers and monitors expiration dates.
• Identifies opportunities for process improvement and makes recommendations to team leader.
• Revises and updates standard operating procedures, as needed.
• May participate in special projects related to problems encountered with testing and instruments, and make recommendations for solutions that will minimize future issues.
• Writes and supports quality records (e.g., Deviations and CAPA) and conducts investigations to determine root cause and possible resolution
• Participates in transfer for Potency and Process Residuals test methods.
• Performs lab housekeeping activities and collaborate with the team to receive the reagents.
• Coordinates with QA to support quality records, revision of SOPs and technical reports
• Works collaboratively across functional groups and departments
• Performs critical reagent qualifications as needed
• Writes memos, compile data, trend data as needed.
• Ability to work in fast paced environment
• Helps train other analysts as needed
• Performs other duties as assigned.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

• High School Diploma and minimum of four (4) years directly related experience.
• Associate's degree in a scientific area of study with three (3) years of related experience
• Bachelor's Degree in a scientific discipline and minimum of two (2) years of direct related experience.
• Experience in one or more of the following areas required ELISA, Bioassays, Cell Culture, Quality Control, and GMP testing.
• Strong knowledge of good laboratory practices.

$74,000-$87,000

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the…