The Senior Quality Control Stability Specialist will join our Quality team to be a key player in all scientific and documentation aspects of stability and related investigations in support of maintaining and improving processes within the CRISPRevolution Production Team at Synthego.
What You'll Do:
- Manage the stability program for sgRNA products manufactured at Synthego.
- Coordinate daily activities for stability testing at prioritization meetings with collaboration from larger QC team, and other stakeholders and management.
- Implement and execute processes for timely transfer of stability samples and scheduled sample pulls to achieve performance metrics and ensure on-time deliverables to customers.
- Author protocols, procedures, reports, deviations, memos and specification documents in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.
- Manage stability databases and tracking metrics with a focus on continuous improvement.
- Conduct QC testing with a variety of analytical techniques such as LC/MS, HPLC, GC, UV/Vis, Endotoxin, Raman spectroscopy, PCR, and NGS to support product stability needs as required.
- Maintain complete and accurate quality control records in conformance with GMP and FDA requirements.
- Maintain Synthego’s stability program and procedures in conformance with ICH guidelines
- Lead and support internal and external customer inquiries and requests as relevant to stability program.
- 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 degree in Biology, Chemistry, Molecular Biology, or equivalent technical field.
- 5+ years in a regulated Quality Control or similar role with extensive working knowledge of cGMP, ICH guidance, CFR 21 Part 11, and change control.
- Be able to analyze, understand and effectively communicate technical material.
- Be able to organize and prioritize tasks in a dynamic work environment.
- Relevant combinations of education, experience, certifications, and merit may be considered upon management review.
Nice to Have:
- Experience with working on a QC team supporting 24/7 production activities.
- Experience as a technical writer, with demonstrable skills in record keeping and good documentation practices.
- Experience in project management.
Company Perks & Benefits
- Equity options
- Medical, dental, and vision benefits
- 401k Program
- Fully stocked kitchen with beverages & snacks
- 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.
The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.
By providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology.
What We Do
Synthego is a genome engineering company enabling the acceleration of life science research and development in the pursuit of improved human health.
The company leverages machine learning, automation, and gene editing to build platforms for science at scale. By vertically integrating hardware, software, bioinformatics, chemistry, and molecular biology, Synthego is at the forefront of innovation advancing the next generation of medicines through providing access to genome editing at an unprecedented scale.
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Our Culture of Diversity: Different Faces from Different Places
At Synthego, our differences make us unique, help us innovate, and allow us to persevere. We stand firmly behind our values, strive to achieve representation, and celebrate diversity in perspectives and backgrounds. We welcome all team members to be their best selves as we move forward towards fulfilling our shared vision of revolutionizing genome engineering technology to help make biological therapies accessible to all patients.
