Process Development Engineer (ADX-345-20)
Process Development Engineer (ADX-345-20)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
POSITION SUMMARY:
We are looking for a driven and talented Process Development Engineer to join the Assay Manufacturing group at ArcherDX. The Assay Manufacturing group is responsible for making rapid and high-quality assays utilizing our Anchored Multiplex PCR (AMP™) technology for use in oncology, immunology, and constitutional genomics. The process development engineer will be responsible for designing and implementing advanced manufacturing procedures and will work closely with R&D, Manufacturing, Quality, and Logistics to support new and existing products. This position is a key part of the greater Assay Development team, requiring strong multi-discipline skills from technical, to writing, to communication.
RESPONSIBILITIES:
- Analyze and improve current production processes
- Develop, test, and implement new manufacturing processes
- Provide expertise in automation, design of processes and scale-up
- Work closely Assay Development Team with expertise in AMP™ panel manufacturing
- Generate documentation including process descriptions, batch records, and SOPs
- Validate and adapt new robotic equipment to support the automation of the production processes
- Communicate effectively with all levels of R&D, production and management
- Coordinate with production and manufacturing for the evaluation and implementation of new equipment and processes
KEY ATTRIBUTES:
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Self-starter
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
EXPERIENCE:
- 2+ years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, process improvement, and validation
- Experience designing, programming and delivering applications in heterogeneous technical environments
- Experience working in a GXP environment with emphasis on GCP, GLP, and GMP
Preferred qualifications:
- Proficiency using high throughput robotic equipment for liquid handling, such as Hamilton, Tecan, and Agilent robots
- Experience in documenting and analyzing experimental data
- Experience in the biotech or pharmaceutical industries
- Experience with product development processes and project management
- Demonstrated understanding of Lean Manufacturing principles
- Experience with digital manufacturing systems, such as ERP, MES and data historian, preferably implementation of such systems
- B.S. or M.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering or equivalent