The Senior Quality Control NGS Specialist will join our Quality team as a Next-Generation Sequencing (NGS) subject matter expert in Quality to be a key player in all scientific and documentation aspects of product development, release, stability, and investigations in support of maintaining and improving processes within the CRISPRevolution Production Team at Synthego.
What You'll Do:
- Lead test method optimization, continuous improvement, development, and validation activities for NGS-based QC assays and test methods.
- Drive QC troubleshooting and laboratory investigation efforts.
- Lead specification setting, design verification and validation, test method validation, failure mode effects analyses, design reviews and tech transfer activities.
- Lead development and continuous improvements for test methods, equipment acquisition and onboarding, sample plans, and validation
- Perform automated and manual assays as detailed in established SOPs and QC test method procedures, including raw material, in-process and finished product.
- Conduct QC testing with a variety of analytical techniques including LC/MS, HPLC, GC, UV/Vis, Endotoxin, and Raman spectroscopy as required.
- Interpret test results against specifications to support material dispositioning.
- Perform testing for product stability, environmental monitoring, endotoxins, and bioburden as required.
- Maintain complete and accurate production records in conformance with GMP and FDA requirements..
- Support routine preventive maintenance, general troubleshooting, general cleanliness and calibration of laboratory equipment.
- Support internal and external customer inquiries and requests as relevant to product quality and integrity.
- Trend QC data results.
- Update departmental SOPs and QC test procedures.
- Order required laboratory supplies, reagents and other consumables.
- Monitor proper storage conditions and expiration dates.
- Dispose of hazardous and biohazardous materials.
- Maintain samples in accordance with established procedures.
- Prepare QC test samples required for QC functional testing.
- Perform other duties as assigned.
About You:
- Bachelor’s or Master’s degree in Biology, Chemistry, Molecular Biology, or equivalent technical field.
- 5+ years industry experience leading implementation of next-generation sequencing (NGS) testing, test method development and validation for in-process and final product release of CRISPR sgRNA or similar product types
- Relevant combinations of education, experience, certifications, and merit may be considered upon management review.
- Be able to analyze, understand and effectively communicate technical material.
- Be able to organize and prioritize tasks in a dynamic work environment.
Nice to Haves:
- Experience in a regulated Quality Control or similar role with working knowledge of CFR 21 Part 11 (electronic records), CFR 21 Part 58 (GLP), and/or CFR 21 Part 210/211 (cGMP)
- Experience with mentoring and training other analysts in NGS on a QC team supporting 24/7 production activities.
Company Perks & Benefits
- Equity options
- Medical, dental, and vision benefits
- 401k Program
- Catered meals on Tuesday and Thursday
- Paid parental leave
- Flexible paid time off
About Us
Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.
Based on a foundation of engineering and chemistry, Synthego leverages automation and machine learning to synthesize high-quality CRISPR reagents for science at scale. Synthego’s mission is to enable agile life science research and development from discovery through clinical trials by providing scientists with comprehensive CRISPR solutions for each phase coupled with full technical and regulatory support from industry-leading experts.
With its technologies cited in hundreds of peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation, enabling the next generation of medicines by delivering genome editing at an unprecedented scale.
