Demo

Analyst I/II, Quality Control Microbiology

Kriya Therapeutics, Inc.
Morrisville, NC Full Time
POSTED ON 1/26/2025
AVAILABLE BEFORE 2/23/2025
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.”

Who You Are

The Analyst I/II, Quality Control Microbiology is responsible for performing a range of microbial testing techniques, including Bioburden, Endotoxin, growth promotion, and other general QC procedures. They are also responsible for EM and gas sampling throughout the manufacturing facility.

How You Contribute

  • Performs routine and non-routine cGMP microbiological testing for samples.
  • Execute phase-appropriate test method validation protocols.
  • Performs Environmental Monitoring and Gas Testing, as needed.
  • Author, review and revise SOP and protocols for microbiological assays.
  • Supports project work and deviations, investigation, CAPAs and continuous improvement initiatives.
  • Supports operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, and sample handling/tracking).
  • Participate in GMP validation activities for laboratory equipment, including the execution of IQ/OQ/PQ Testing.
  • Ensure continuous lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits.
  • Other laboratory responsibilities as required.

Education & Experience

What You Bring to the Team

  • BS degree in Chemistry, Microbiology, Biological Sciences, or related field
  • 1-2 years of experience in a cGMP environment is required
  • Strong good documentation practices
  • Previous experience in a sterile manufacturing processing is preferred.
  • Previous experience in gene therapy is preferred
  • An equivalent combination of education and experience is acceptable

Competencies

  • Hands on experience with environmental monitoring and gas monitoring
  • Hands on experience with microbial testing (i.e., bioburden and endotoxin testing)
  • Excellent verbal and written communication skills, detailed-oriented personality
  • Ability to work in a dynamic team environment.
  • Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment

Working Conditions

  • Primarily a laboratory setting
  • May involve standing, sitting, and using laboratory equipment for extended periods.
  • Some lifting of equipment or materials may be required.

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.

What We Offer

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 Equityand 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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