Director, Production and Quality Management
Synthetic Genomics, Inc. - La Jolla, CA

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The Director of Production and Quality Management is responsible for implementing and managing the procedures for production, data management and quality assurance . Specifically, the professional is responsible for developing and executing the company’s manufacturing, process control and quality management system to meet industry standards, company goals and customer requirements.

Required Skills
  • Work as part of the managem ent team to translate the business goals into production and quality goals
  • Understand industry best practices in terms of production management and quality control procedures and systems and identify best practices for company
  • Es tablish budget and requirements and infra-st ructure required to support operations and quality assurance
  • Design and develop conceptual process designs covering production and quality control steps
  • Lead the implementation and management of production and operational protocols for DNA and RNA synthesis
  • Implement and manage best in class production, data management and quality control operations
  • Ensure compliance with all laboratory procedures, including GXP’s (cGMP, GMP, GLP) , quality and safety policies and best practices
  • Ensure seamless data security and management throughout the production workflow
  • Manage priorities and production orders to create production schedules and meet turnaround requirements
  • Ensure seamless integration with front-end (order entry), back-end (shipping, invoicing, customer service) and suppliers process
  • Create, implement, evaluate the company’s production management policies, standards, procedures and plans
  • Review supplier performance
  • Develop and maintain QA and performance standards and tracking systems
  • Participate in customer, supplier and internal meetings
  • Manage PMS and QMS to develop reporting procedures
  • Lead production and quality management communications
  • Oversee internal audit
  • Ensure compliance wi th all laws, regulations and required certifications

Required Experience
  • Requires a Masters or Ph.D. in Engineering , Molecular Biology or related field
  • At least 10 years relevant experience in p roduction or quality management
  • Requires a knowledge of DNA sequencing and synthesis processes
  • Track record managing biotechnology products production and quality assurance
  • Experience establishing and implementing production, quality management, performance and cost protocols , and manufacturing management systems
  • Well versed with regulatory standards and experience implementing cGMP standards and protocols
  • Must have team-oriented management experience and leadership ability, including supervision of scientists
  • Highly-motivated, innovative professional with critical thinking, organizational and problem-solving skills to independently design, execute, troubleshoot and interpret experiments
  • Excellent communication and interpersonal skills to effectively participate in a multidisciplinary team

About this company
Synthetic Genomics, Inc., a privately held company founded in 2005, is dedicated to developing and commercializing genomic-driven solutions...