Quality Control Manager, Analytical & Stability
Redwood City, CA, USA
Posted on Friday, December 8, 2023
We are seeking an exceptional individual to join us as the Quality Control Manager for Analytical laboratories and Stability Program. This position reports to the Director of Quality and has direct responsibility for the Quality Control Analytical and Stability functions of the organization.
What You'll Do
- Manages the development, transfer and validation of analytical methods to QC or external testing labs.
- Manages the Stability Program and develops studies for multi-modality projects.
- Manages raw material, in-process and release testing in support of manufacturing.
- Manages the Product Retention Program for GMP manufacturing.
- Responsible for OOS, lab and protocol deviations. Implements corrective action plans when necessary.
- Ensures QC instrumentation, lab and sample flow is in compliance to GMP requirements.
- Provides oversight of external testing labs for in-process and final release assays.
- Review of records, generation of CoAs for product release.
- Manages improvements to existing QC processes through implementation with minimal assistance, including implementation of new QC equipment, methods, procedures, and/or software
- Provides 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.
- Responds to internal and external customer inquiries and requests as relevant to QC.
- Investigates customer complaints and obtains data for customer inquiries that are relevant to QC.
- Leads the QC team to sustain a scalable group to support multiple programs.
- Manage and mentor staff members and contribute to a high performing team.
- Performs other duties as necessary.
- 5+ years relevant experience in Quality Control at a life science company with increasing levels of responsibility, prior management experience is preferred.
- Minimum of Bachelor’s Degree in a scientific discipline, M.S or PhD in a scientific discipline (Chemistry or Biochemistry) preferred
- Experience with QC lab instrumentation and equipment, specifically HPLC, LC-MS, ESI-MS, PCR, NGS
- Possess working knowledge of cGMP
- Possess working knowledge of quality management systems (QMS), processes, and procedures
- Familiarity with problem-solving, root cause analysis tools, impact assessment, and CAPAs
- Experience with QMS software platforms. Experience with Arena Solutions PLM is a plus
- High degree of attention to detail
- Strong documentation skills
- Responsible and accountable with non-compromising high ethical standards
- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
Company Perks & Benefits
- Generous equity
- Medical, dental, and vision benefits
- 401k Program
- Subsidized catered lunches and dinners with stocked kitchens & snacks
- Paid parental leave
- Flexible paid time off
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.