Sr. Quality Control Specialist

Synthego

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 06/08/2021
  • Website: synthego.com
  • Company Address: 3565 Haven Ave, Suite 1, Menlo Park, CA, 94025, US

About Synthego

Synthego is turning molecular biology into an information science. We're building hardware facilities that abstract biological syntheses and research into software.

Our vision is to bring automation to genome engineering, enabling scientists to run their own fully-automated laboratory at low cost, performing millions of controlled, repeatable experiments per day without human error.

Founded by former SpaceX engineers, Synthego is a leading provider of genome engineering solutions. The company’s flagship product, CRISPRevolution, is a portfolio of synthetic RNA designed for CRISPR genome editing and research.

We are venture backed by Founders Fund, Menlo Ventures, 8VC, Intel Capital.


Rev 20170116

Job Description

The Sr. Quality Control Specialist 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 CRISPRevolution Production Team. 

What You'll Do

    • Provide guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews.
    • Provide guidance to test methods, equipment acquisition, sample plan definition, and test method validation development.
    • Conduct Analytical method development with support from Chem Development team
    • Write/execute QC method transfer validation activities
    • Perform Equipment IQ/OQ/PQ activities
    • Manage stability program and activities
    • Provide guidance and decisions on product development activities to ensure compliance with internal procedures and applicable regulatory or international standards.
    • Document, analyze, and interpret QC and experimental data.
    • Support QC chemistry/biological testing of raw materials, in-process, final and stability
    • Responds to internal and external customer inquiries and requests as relevant to product quality or integrity.
    • Investigates customer complaints and obtains data for customer inquiries that are relevant to QC.
    • Manages development or transfer of new QC processes or improvements to existing QC processes through implementation with minimal assistance, including implementation of new QC equipment, methods, procedures, and/or software.
    • Conducts experimentation in the synthesis, characterization, and/or functional integrity of oligonucleotides or Raw Materials.
    • Develops equipment and process validation plans related to QC.
    • Recommends testing for manufacturing-related non-conformances and CAPAs.
    • Management of contract testing labs for in-process and final release assays.
    • Provides troubleshooting support for analytical equipment (LC-MS, HPLC, GC)

About You

    • Ability to identify customer needs and issues and develop realistic solutions to meet needs and solve problems.
    • Ability to communicate recommendations and decisions across the organization.
    • 3+ years in a regulated Quality Control or similar role
    • Knowledgeable in statistical analysis and design of experiments.
    • Bachelor’s Degree in a Chemistry or Biochemistry or science discipline or equivalent experience.
    • Possess working knowledge of cGMP 
    • Strong communication skills
    • High degree of attention to detail
    • Experienced with analytical method development and validation required
    • Analytical instrumentation experience, including instrument troubleshooting, is preferred (e.g. ESI-MS, LC-MS, HPLC, GC, bioburden testing, endotoxin testing, KF, UV/VIS etc.)
    • Hands on experience with LC-MS, GC-FID and HPLC/UPLC.
    • Experience in instrument software such as UNIFI, Empower, Chromeleon and others a plus.
    • Experience with Equipment Qualification
    • Experience in Change Control, Laboratory Investigation and CAPA
    • Knowledgeable of ICH guidance, FDA regulations, CFR 21 part 11 compliance.
    • Understand Stability Study program according ICH guidelines
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.

Related Jobs

Software Engineer (Front-End), Instruments

Synthego - Redwood City, CA, US

Sr. Full Stack Software Engineer, LIMS

Synthego - Redwood City, CA, US

Research Associate, Engineered Cells

Synthego - Redwood City, CA, US

Cell Culture Banking Specialist, Engineered Cells

Synthego - Redwood City, CA, US

Sr. DevOps Engineer

Synthego - Redwood City, CA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.