Product Sustaining Manager (ADX-39-21) at ArcherDX
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.
The Product Sustaining Manager, will work closely with Operations, Research and Development (R&D) and Quality Control/Assurance (QC/QA) teams to ensure compliance and efficient processing of ArcherDx’s products. They are responsible for different duties related to troubleshooting and collaborating with Contract Manufacturing Organizations and internal Production labs at ArcherDx
Job performance will involve a variety of activities including:
- Lead and collaborate with R&D teams to design and execute experiments related to troubleshooting of all steps in an NGS assay
- Accurately document all necessary relevant information in a clear and concise manner per cGxP
- They will collaborate with teams on technology operations, such as impact assessments and continuous improvement for change control
- Collaborate with cross functional teams on the root cause investigations on issues related to the IVD products
- Be the technical lead from Operations side and collaborate with cross functional teams to provide technical support to the field team
- Provide feedback on and collaborate on process improvements and cost effectiveness in manufacturing processes
- Work closely with Contract Manufacturing Organizations, according to established product development timelines and help with troubleshooting in manufacturing related issues
- Collaborate with Process Development and Tech Transfer teams on a technical level as needed
- Lead the Process Development for sustaining the product
- Perform other duties as assigned by supervisor
- Review, understanding, and compliance with ArcherDX HIPAA security policies and procedures.
- Minimum of 6 years’ experience in laboratory testing
- 3+ years of experience in industry setting
- Previous laboratory experience with statistical data analysis, Next Generation Sequencing, qPCR/PCR and general molecular biology techniques and equipment
- Knowledge of cGMP/CFR/FDA regulations
- Strong leadership and communication skills
- 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
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize and prioritize tasks to efficiently move projects forward
- PhD/MS degree with 1-2 years of experience, or
- BS degree with 4-6 years experience, in biology, molecular biology, biochemistry or a related field and/or equivalent combination of education and experience.