Quality Control Analytical Associate (Open Rank)

About Wheeler Bio

Wheeler Bio is a biomanufacturing company designed to accelerate the translation of therapeutic innovation into clinical impact. Through integration with pre-clinical discovery, Wheeler is democratizing access to comprehensive discovery-to-IND programs with its rapid, high-quality biomanufacturing and Modular CMC platform. With an initial focus on antibody therapeutics, the company offers emerging biopharma companies a faster and more predictable path to the clinic by avoiding the critical gaps between discovery and early development. Wheeler’s unique partnering model is built on shared success, creating a singular focus on quality, speed, and lasting collaborations. Wheeler Bio is headquartered in Oklahoma City.

Quality Control Analytical Associate (Open Rank)

Wheeler Bio is seeking a motivated, structured individual with a passion for quality and fast-paced environments to join the Quality Control Analytical team. The QC Analytical Associate will participate in routine analytical testing according to written procedures (e.g., in-house SOPs, client test methods) for Quality Control release and stability testing. This position will participate in method transfer from Analytical Development and may perform non-GMP testing in R&D.

Responsibilities:

• Independently performs laboratory activities, including but not limited to, reagent preparation, laboratory cleaning, maintenance/monitoring of laboratory equipment, routine testing of client samples, and generation of routine cGMP and R&D reports with a focus on quality and timeline.
• Follows all SOPs, TRs and cGMP as they relate to established processes for laboratory operations and execution of routine testing for release and/or stability samples.
• Participates in method qualifications and transfer from Analytical Development.
• Demonstrates proficiency in performing different routine tests within the Quality Control laboratory.
• Maintains a laboratory notebook according to company guidelines.
• Uses and applies complex instrumentation, computer systems and software for data acquisition and analysis.
• Analyzes data and reports results of experiments and procedures.
• Composes high quality documentation including deviation reports and change control documentation under guidance.
• Competently performs peer review of data.
• Ability to work in a structured and regulated environment.
• Ability to work with team members to troubleshoot and solve problems to meet project needs.
• Maintains analytical instrumentation as needed and interfaces with external vendors for instrument installation and operation qualifications.
• Maintain up to date training records on all procedures and protocols applicable to work duties.
• Ensures lab is maintained (organized, clean, properly supplied).
• Integrates ongoing quality and operational improvement strategies into workflows.
• Maintains a safe working environment by adhering to company policies and procedures.
• Complies with all pertinent regulatory standards regarding environment, equipment, and testing services.
• All other duties as may be assigned.

Knowledge / Skills / Experience Requirements:

• Preferred Bachelors degree in relevant scientific discipline or equivalent experience in Quality Control testing within a regulated industry.
• Preferred knowledge of and experience with various analytical techniques (e.g., HPLC, ELISA, BLI, bioassays).
• Ability to work independently with supervision.
• Work professionally as part of a team.
• Excellent communication and organizational skills.
• Ability to generate technical reports.
• Ability to clearly communicate scientific information.
• Ability to write and perform detailed analytical procedures.
• Basic knowledge of FDA, ICH, EMA, JP, and other regulatory guidance on CGMP manufacturing.

Working Conditions and Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Wheeler will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. While performing the duties of this job, the employee is regularly required to:

• Prolonged sitting, standing, walking, bending, stooping, and stretching
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopies, telephone, calculator, other office equipment, along with specialty analytical equipment such as pipettes
• Occasionally lifting 50 pounds maximum
• The position is offered on-site and is not eligible to work from home