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Director of Process Development

Codex DNA
San Diego Metropolitan Area

The Director of Process Development is recognized as a subject matter expert in product and process development for new products and technologies. This role will provide technical expertise for all activities within the product and process development areas. This role will spend most of their time identifying, initiating, and implementing high value continuous improvement and cost saving projects for Operations. The ideal candidate will optimize our synthetic biology DNA, mRNA and protein synthesis products and integrate with related functions. This position is a leadership role within the organization and is accountable for driving change, establishing sustainable business processes, improving products and manufacturing processes, and providing management with actionable business and product data. The position requires exceptionally strong communication, interpersonal and project management skills to effectively coordinate activities and deliver results. This role will report to the Vice President of Global Products & Quality. A successful candidate will have an enthusiastic entrepreneurial work ethic. This person will work closely with personnel from the Process Development, R&D, Manufacturing, Engineering, Quality, and Operations Teams.

Essential Duties and Responsibilities:

The position requires a creative individual who can work hands-on as part of a dynamic and integrated team. The candidate will also be the primary technical expert for downstream product development and upstream process development activities, providing technical leadership, troubleshooting support and guidance for manufacturing and quality control processes through product/technology transfer from Research and Development to Operations. Responsibilities include:

  • Lead the transfer and release of new products, technologies, and processes into operations
  • Lead process validation and implementation of new automation platforms for the manufacturing and testing of DNA, mRNA, and proteins products to ensure requirements and specifications per Codex DNA standards
  • Develop and manage short/long term strategies, goals, objectives, and associated budgets required to ensure appropriate department operations and site deliverables
  • Develop workflows to improve manufacturing and quality control testing, document procedures and write required documentation.
  • Drive continuous improvement project to advance processes and capabilities for operations. Advocate strategically and operationally effective solutions to complex problems.
  • Analyze and direct cost reduction and resolve production and quality issues.
  • Closely align with senior leaders across the organization to develop value propositions, work within PMO to prioritize and execute projects.
  • Establish and monitors process metrics and develops action plans as needed
  • Act as point of contact for quality investigations, root cause analysis, corrective actions, preventive actions, and quality system improvement initiatives
  • All other duties as assigned or necessary

Required Qualifications:

  • 8-10 years of experience in developing new processes and automation of biological workflows for gene synthesis, DNA manipulation, PCR, cloning or services related operations
  • Strong technical knowledge of synthetic biology, molecular biology, specifically gene assembly, cloning, maxiprep and sequencing
  • Excellent knowledge of quality management systems, ISO 13485, ISO9001. GMP Manufacturing experience is required
  • Experience with LEAN, Six Sigma, 5S, GMP manufacturing, and other process improvement tools required
  • 5+ years cross-functional or program management experience at a leadership level.
  • Excellent communications, teamwork, and presentation skills.
  • Detailed and service oriented individual.

· Knowledge of Microsoft Office and Outlook required.

  • Highly adaptable and independent
  • Thrive in a start-up, rapidly growing company environment
  • Excellent verbal and writing skills, great computer skills
  • Take initiative and have a growth mindset

Education Requirements:

· BS/MS degree in Molecular Biology, Biochemistry, or related field. PhD degree strongly preferred

Travel Required:

  • 0-25%

Working Conditions: (Select from Below is applicable)

  • As a critical and essential role, the candidate must be willing and able to travel to the San Diego, CA office to report to work 5 days a week. We have protocols in place to provide a safe, socially distanced work environment.

Job type: FULL_TIME

Experience: 5 Year

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