Manager, Quality Control Laboratory Operations na Kriya
Kriya · Morrisville, Estados Unidos Da América · Onsite
- Senior
- Escritório em Morrisville
About Kriya
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.”
Role Overview
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.
Key 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.
Experience & Skills
- BS degree in Chemistry, Microbiology, Biological Sciences, or related field
- Advanced degree preferred
- 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
Work Environment
- Primarily in an office or laboratory setting
- May involve standing, sitting, and using laboratory equipment for extended periods.
Discover True Collaborative Teamwork
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.
Rewards & Benefits
Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more!
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.
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