Quality Control Technical Services Manager

Kriya Therapeutics•Morrisville, NC

49d

About The Position

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.

Requirements

BS degree in Chemistry, Microbiology, Biological Sciences, or related field
6+ years of relevant experience
Strong knowledge of cGMP, SOPs, change controls, deviations, and other quality control processes
Excellent and effective written, verbal communication and presentation skills
Experience in designing, trending, and reviewing stability studies.
Highly organized and demonstrated ability to manage critical activities with strict requirements.

Nice To Haves

Advanced degree preferred
Previous experience supervising/managing people or large projects is strongly preferred
An equivalent combination of education and experience is acceptable

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.