The Quality Control Manager, Analytical will join our Quality team 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:
- Manage the development, transfer and validation of analytical methods to QC or external testing labs.
- Manage raw material, stability, in-process and release testing in support of manufacturing.
- Manage the Product Retention Program for GMP manufacturing.
- Responsible for OOS, lab and protocol deviations. Implements corrective action plans when necessary.
- Ensure QC instrumentation, lab and sample flow is in compliance to GMP requirements.
- Provide oversight of external testing labs for stability, in-process and final release assays.
- Review of records, generation of CoAs for product release.
- Manage improvements to existing QC processes through implementation with minimal assistance, including implementation of new QC equipment, methods, procedures, and/or software.
- Provide oversight of analytical methods for GMP manufacturing.
- Support external inspections/audits.
- Establish Quality Metrics and report to executive team
- Provide guidance and decisions on product development activities to ensure compliance with internal procedures and applicable regulatory or international standards.
- Respond to internal and external customer inquiries and requests as relevant to QC.
- Investigate customer complaints and obtain data for customer inquiries that are relevant to QC.
- Lead the QC team to sustain a scalable group to support multiple programs.
- Manage and mentor staff members and contribute to a high performing team.
- Communicate effectively with other departments and/or internal groups.
- Perform other duties as assigned.
About You:
- Master’s or 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.
- Prior team management experience is strongly preferred.
- Experience with QC lab instrumentation and equipment, specifically HPLC, LC-MS, ESI-MS, PCR, and NGS.
- Possess working knowledge of cGMP.
- Be able to analyze, understand and effectively communicate technical material.
- Experience in aseptic techniques, sterile gowning procedures and clean room operations.
- Strong experience in applying GMP in QC lab in conformance with relevant regulatory standards.
- Experience in conducting lab investigations, including familiarity with problem-solving, root cause analysis tools, impact assessment, and CAPAs
- Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Relevant combinations of education, experience, certifications, and merit may be considered upon management review.
Nice to Have:
- Experience with managing a QC team supporting 24/7 production activities.
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.
////
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.
