Manager, Quality Control Laboratory Operations

Kriya Therapeutics Inc•Morrisville, NC

48d

About The Position

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.” The Manager of the Quality Control Laboratory Operations’ group is responsible for all analytical testing activities, data review, equipment management, laboratory supply chain, and driving operational excellence. They are expected to design and manage the GMP systems within their area of responsibility while fostering a culture of scientific rigor and continuous improvement. This leader develops talent, empowers their team to deliver high-quality results, and manages the day-to-day activities of direct reports with a focus on collaboration and professional growth.

Requirements

BS degree in Chemistry, Microbiology, Biological Sciences, or related field
6+ years of relevant experience
Previous experience supervising/managing people or large projects is strongly preferred
An equivalent combination of education and experience is acceptable
Experienced in performing one or more of the following within a GMP or GLP environment. Cell-based potency, PCR, HPLC, and/or CE.
Previous experience with analytical method qualification/validation.
Highly organized and demonstrated ability to manage critical activities with strict requirements.
Strong knowledge of cGMP, SOPs, change controls, deviations, and other quality control processes
Excellent and effective written, verbal communication and presentation skills

Nice To Haves

Advanced degree preferred

Responsibilities

Responsible for managing all GMP analytical testing activities across multiple programs. Testing responsibilities include executing method validation, release, and stability testing, reviewing analytical data for accuracy and GMP compliance, investigating Out-of-Specification results, and generating Certificates of Analysis.
Supporting the completion of laboratory equipment qualification, calibration, maintenance, and troubleshooting to ensure operational readiness and compliance.
Develop any procedures and supporting training materials for activities occurring within the laboratory.
Ensuring the completion of investigations and all associated CAPAs occurring within the laboratory.
Ensure continuous compliance with applicable cGMP regulations and SOPs, and support regulatory audits.
Ensure direct reports receive the proper support, coaching, and career development necessary to thrive within their position and at Kriya.