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Production Specialist, Clinical Operations

Company: Synthego Corporation
Location: Redwood City
Posted on: May 21, 2023

Job Description:

Synthego is enabling genome engineering at scale with a blend of scientific instrumentation, industrial automation, and data science. Our team of scientists and engineers are putting multidisciplinary fields together to solve problems that no one field can tackle alone.We are searching for motivated, efficient, and hands-on individuals interested in advancing science through the manufacturing of our CRISPR products. As a Production Specialist at Synthego, you will join our growing operations team and have direct responsibility for the end-to-end manufacturing of our GMP sgRNA products. This role requires strong attention to detail, experience working in a GMP-compliant environment, and oligonucleotide manufacturing.Day Shift:Tuesday - Saturday; 6:30am- 3:00pmTraining Schedule: Training will take up to 3 months. Training is typically conducted M - F from 6:30am to 3:00pm, however, is subject to change due to staffing and training needs. After training is complete, you will work the hours/days of the week you were hired for.What You'll Do

  • Responsible for end-to-end oligonucleotide manufacturing including reagent preparation, equipment set-up, synthesis and post-processing (cleavage and deprotection, purification, and lyophilization) of GMP sgRNA products
  • Follow established SOPs and revise SOPs, as necessary to ensure compliance.
  • Properly record, analyze, and maintain batch records and supporting data per good documentation practices
  • Execute batch production records or protocols independently, efficiently, and in compliance with site and quality management system requirements
  • Collaborate with Supply Chain, Quality Assurance, Warehouse, and other cross-functional teams to meet deadlines
  • Practice continuous improvement by contributing ideas and suggestions to new and existing processes
  • Operate complex robotic high-throughput systems to manage products through a highly automated workflow
  • Organize, stock, and maintain work area to 5S and safety standards
  • Capture production data in compliance with site and quality management system requirements.
  • Identify, communicate, and escalate processing or quality related issues.
  • Ability to author documents such as protocols, change control records, deviation, master production records and SOPs.About You
    • BS/MS in Chemistry or a relevant sciences field
    • 2+ years of pharmaceutical and/or industry experience in cGMP/cGLP a plus
    • Desire to work in a fast-paced, collaborative startup environment
    • Experience running HPLC and solid phase extraction workflows a plus
    • Strong commitment to quality
    • Demonstrates strong interpersonal and communication skills (both written and verbal)
    • Ability to work independently and as part of a team, to meet departmental goals
    • Self starter who is comfortable working with limited guidelines
    • Able to lift/move up to 25 pounds.
    • Comfortable to sit and/or stand for extended periods (up to 4 hours)Company Perks & Benefits
      • Generous equity
      • Medical, dental, and vision benefits
      • 401k Program
      • Subsidized catered lunches and dinners with fully stocked kitchen & snacks
      • Onsite Gym
      • Daily Shuttle bus to & from San Francisco
      • Paid parental leave
      • Flexible paid time off
      • Learning and Development resources$33 - $40 an hourCompensation range is for Production Specialist - Senior Production Specialist.About UsSynthego 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.

Keywords: Synthego Corporation, Redwood City , Production Specialist, Clinical Operations, Professions , Redwood City, California

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