Quality Control Technical Services Manager at Kriya Therapeutics Inc

Morrisville, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Feb, 26

Salary

0.0

Posted On

04 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, GMP, Stability Studies, Sample Management, Laboratory Management, Data Trending, Communication Skills, Team Leadership, Regulatory Compliance, Training Development, Technical Excellence, Project Management, Coaching, Accountability, Innovation

Industry

Biotechnology Research

Description

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 Technical Services’ group is responsible for stability, sample management, third-party laboratory management, incoming material sampling/inspections, and LIMS support. They are expected to design and manage the GMP systems within their area of responsibility while building a high-performing team that drives cross-functional success. This leader mentors and develops direct reports, promotes accountability and innovation, and manages day-to-day activities with an emphasis on strategic coordination and technical excellence. Key Responsibilities * Responsible for managing the GMP stability program across multiple programs with the support of direct reports. The stability program responsibilities include designing the stability studies, managing the pulls, tracking stability testing, issuing time point CoAs, trending data, and authoring the final stability reports. * Overseeing the process for the aliquoting and distribution of manufacturing, stability, and incoming material samples. * Maintain third-party testing laboratory relationships and ensuring proper GMP oversite. Ensure samples are shipped and subsequent data is being reviewed in a timely manner. * Manage the process for the QC inspection of incoming materials, including sampling, and submission of samples for testing. * Manage the employee(s) responsible for LIMS master data creation and approval. * Develop any procedures and supporting training materials for their areas of responsibility. * Support/address investigations occurring within their areas of responsibility. * 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 * Experience in designing, trending, and reviewing stability studies. * 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.

Responsibilities

The Manager is responsible for managing the GMP stability program and overseeing the process for sample management and QC inspections. They will also maintain third-party laboratory relationships and ensure compliance with cGMP regulations.