Analyst II/Senior Analyst, Quality Control

Kriya Therapeutics • Morrisville, NC

3d • Onsite

About The Position

This role is responsible for performing a range of Quality Control testing techniques on production facilities, intermediates, and products, and includes authoring SOPs / Protocols / Reports. This position will be hired at either the Analyst II or Senior Analyst level; scope of ownership and level of independence will align with the successful candidate's experience.

Requirements

• BS/Bachelor's degree in Chemistry, Biochemistry, Biological Sciences, or related field.
• 3+ years of experience in a cGMP, QC, or a similar laboratory environment is required.
• Previous experience performing HPLC, PCR, or cell-based potency testing is required.
• Strong good documentation practices.
• Strong technical writing skills.
• Excellent verbal and written communication skills, detailed-oriented personality.
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.

Nice To Haves

• 4+ years preferred for consideration at the Senior Analyst level.
• Previous experience in gene therapy is preferred.
• An equivalent combination of education and experience is acceptable.
• Experience training and/or mentoring laboratory analysts preferred.

Responsibilities

• Performs routine and non-routine cGMP testing for samples, as well as provide primary support for training and mentoring of laboratory personnel, as needed.
• Leads, develops, and executes QC methods across a range of techniques, including HPLC, CE, PCR, and cell-based potency methods.
• Verifies and reviews QC data.
• Leads project work and deviations, investigation, CAPAs and continuous improvement initiatives.
• Serves as SME for certain assays / instruments / equipment.
• Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, and sample handling/tracking).
• Participate in GMP validation activities for laboratory equipment, including the onboarding and execution of IQ/OQ/PQ Testing.
• Ensure continuous lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits.

Benefits

• Flexible Time Off
• Paid Parental & Medical Leave
• Paid Company Holidays
• Fertility & Family Building Benefits
• Medical, Dental, and Vision Insurance
• Employee Assistance Program (EAP)
• Life Insurance
• Short- and Long-Term Disability Coverage
• Equity
• 401(k) with Company Match
• Identity Theft Protection

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level