Scientist I/II, IVD Assay Development, Oncology R&D at Invitae (Greater Boulder Area, CO)
The Scientist I/II in the Solid Tumor IVD Assay Development Team contributes key capabilities and expertise to our regulated product development efforts. In collaboration with project leads, the Scientist I/II position is responsible for development, execution, and critical evaluation of experimental designs in support of regulated products. This person will work closely with other assay development scientists, data analysts, statisticians, quality, regulatory, clinical, and manufacturing personnel for data generation and document generation, revision, and approval.. This position is a key part of the greater IVD Assay Development team, requiring strong data analysis and science communication skills..
Job performance will involve a variety of activities including:
- Collaborate with team members to design studies, write protocols, conduct analysis, and write reports for assay development, verification, and validation to support clinical and regulated applications
- Generate ideas to improve existing technology and drive future technology
- Identify opportunities for process improvements
- Generate quality control or manufacturing and design control documentation
- Interpret scientific results and provide recommendations for next steps
- Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
- Additional duties as assigned.
- 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 written and verbal communication
- Strong science acumen
- Self-directed self-starter who needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward
- Clear, accurate, honest
- 5+ years of laboratory experience (required)
- 2+ years in an industry setting (preferred)
- Proficiency in PCR, qPCR, and molecular genetic techniques (required)
- Familiarity with NGS and bioinformatics (required)
- Familiarity with statistical analyses (required)
- Facility with R, python, or other coding languages (required)
- Expertise in authoring and presenting scientific content (required)
- Familiarity with IVD and CDx guidelines from FDA, CLSI, etc. (preferred)
- Familiarity with principles of design control (preferred)
- BA/BS, MA/MS, or PhD in biochemistry or related field and/or equivalent combination of education and experience
- This position may supervise junior team members.
- This hire will slowly move into a role of increasing responsibility as their knowledge expands.
- This position operates in a professional office and laboratory environment.
- The job requires an individual to routinely use standard office equipment such as computers, phones, and photocopiers.
- This job requires an individual to routinely use standard laboratory equipment such as pipettes, centrifuges, and thermal cyclers.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- The employee may occasionally lift and/or move up to 20 pounds.
- The employee is regularly required to talk or hear.
- The employee is frequently required to sit, use hands to fingers, handle or feel and reach with hands and arms.
- The employee is occasionally required to stand or walk.
POSITION TYPE/EXPECTED HOURS OF WORK:
This is a full-time position working standard business hours. This position may require the flexibility to work diverse schedules, including evenings, weekends, and holidays.
This job description is not designed to cover nor contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
In Colorado, our competitive compensation package includes a base salary starting from $88,800.00. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
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.