Tech Transfer Associate (ADX-374-20) at ArcherDX
The Tech Transfer Associate position is responsible for assisting in tech transfer and the commercial operations processes. This position will work closely with Operations, Research and Development (R&D) and Quality Control/Assurance (QC/QA) teams to ensure compliant and efficient processing of manufactured product for in vitro diagnostic assays.
- Job performance will involve a variety of activities including:
- Assist with Technical Transfers from IVD AD team and R&D into Operations
- Assist and Collaborate cross functionally to manufacture engineering builds and pilot builds of assay components
- Investigate and troubleshoot product testing and process abnormalities
- The development and technical transfer of commercial Operations processes
- Assist in the revisions and review of Manufacturing procedures, test methods, work instructions and travelers (batch records)
- Collaborate with various functional groups like QC, Manufacturing, Logistics and Engineering to assist in Technical transfer of the processes
- Perform other duties as assigned by supervisor
- Review, understanding, and compliance with ArcherDX HIPAA security policies and procedures.
- Minimum of 4 years’ experience in laboratory testing
- 2+ years of experience in industry setting is preferred
- 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 to efficiently move projects forward
- Bachelor's degree required.