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Sr. Specialist, Quality Control

Employer
Kriya Therapeutics
Location
Morrisville, NC
Start date
Jun 17, 2022

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC

COMPANY SUMMARY

Kriya Therapeutics is a transformative gene therapy company with the intent to expand gene therapy to broader disease indications leveraging in house manufacturing capabilities and novel therapeutic designs. 

Our mission is to identify, develop, and bring to market high-impact therapies that have the potential to improve the lives of patients with prevalent and severe chronic diseases.  We target  conditions where the underlying biology is well-understood, rationally designing gene therapies for metabolic and other inflammatory diseases . Our lead programs are focused on the treatment of metabolic diseases such as diabetes (Type 1 and 2) and severe obesity.  

Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. Kriya employees are motivated by the promise of novel drug development and is driven to find more efficient and effective ways to conduct scientific and clinical evaluations that rapidly deliver impactful medicines to patients in need.  Our leadership team has a track record bringing innovative new therapeutic treatments to a global market, and along with our seasoned board of directors, is fully committed to the responsible pursuit of transformative therapies that significantly impact patient health and wellbeing.

OVERALL SUMMARY 

We are seeking a Quality Control (QC) Specialist/Sr. Specialist to join the Quality Control team at Kriya Therapeutics.  This individual will play a critical role in the qualification of new analytical methods for the QC laboratory using a range of technologies, such as HPLC/UPLC, ELISA, qPCR, ddPCR, capillary electrophoresis, and a range of other potential technologies.  In addition, the individual will play a key role in the set up and ongoing support a new laboratory information management system (LIMS).  They will also own or support change controls and laboratory investigations, as needed.

PRIMARY RESPONSIBILITIES:

  • Coordinate with the Analytical Development to transfer technical knowledge of new methods to the QC labs
  • Own and execute method qualification/validation protocols
  • Develop laboratory procedures, electronic notebook (ELN) templates, and supporting training materials
  • Support the implementation of a new LIMS system by generating product, project, and stability builds
  • Execute routine analytical testing
  • Support/address investigations regarding out of specifications (OOS) results, invalid or atypical test results following quality procedures
  • Develop, revise, and review general laboratory SOPs and stability protocols and reports as assigned by management
  • Train and provide technical assistance and guidance to staff with regards to lab safety and analytical methods 
  • Ensure continuous lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits

SKILLS REQUIREMENTS:

  • Minimum BS degree in Chemistry, Microbiology, Biological Sciences, or related field with 5+ years of relevant experience 
  • Experience in developing materials and training QC Analysts in quality principles, procedures and analytical methods/equipment. Hands-on experience with analytical testing in a GMP or GLP environment
  • Experience with HPLC is preferred
  • Demonstrated experience in analyzing and interpreting data and information, drawing conclusions and making recommendations
  • Strong knowledge of cGMP, SOPs, change controls, deviations, and other quality control processes
  • Excellent and effective written, verbal communication and presentation skills


Kriya is an equal opportunity employer. 

We celebrate diversity and are committed to creating an inclusive environment for all employees.

 


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