Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.
The Tech Transfer Associate position is responsible for performing tech transfer of the commercial operations processes for in vitro diagnostic assays. 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:
- Perform Technical Transfer of IVD assays from IVD AD team and R&D into Operations
- Perform Technical Transfer of commercial operations processes
- Utilize technical knowledge of IVD Assays and user needs to guide upstream development activities
- Implement subject matter expert knowledge for document and process creation during process development
- Plan and perform activities needed to manufacture engineering builds and pilot builds of assay components
- Utilize technical expertise to plan and support scale-up of assay components
- Communicate with contract manufacturing organizations to ensure successful external technical transfer or implementation of process/product improvements
- Use independent judgement to troubleshoot product testing and process abnormalities
- Perform technical impact assessments for product or process nonconformance, corrective actions or supplier issues
- Independently analyze and present technical data in a precise manner and communicate results and recommendations to cross functional teams
- Serve as point of contact cross functionally to drive progress and timely completion of projects
- Author technical documentation in support of technical transfer needs
- Revise and review manufacturing procedures, test methods, work instructions and travelers (batch records)
- Collaborate with various functional groups such as QC, Manufacturing, Logistics and Engineering to assist in Technical Transfer of the processes and test methods
- Collaborate with Project Management Office as needed to support technical transfer
- 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
- MS degree with 0-1 year of experience, or
- BS degree with 2-4 years experience, in biology, molecular biology, biochemistry or a related field and/or equivalent combination of education and experience.
In Colorado, our competitive compensation package includes a base salary starting from $26.45 per hour. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.