Senior/Principal Scientist, IVD Assay Development, Oncology R&D
The Senior/Principal Scientist in the Solid Tumor IVD Assay Development Team contributes key capabilities and expertise to our regulated product development efforts. The Scientist is responsible for development, execution, and critical evaluation of experimental designs in support of regulated products. The candidate will combine knowledge of molecular biology and genomics with scientific and quantitative expertise to deliver actionable insights to the team. This person will interface with other assay development scientists, data analysts, statisticians, quality, regulatory, clinical, and manufacturing personnel to translate laboratory processes from feasibility to validation. This position is a key part of the greater IVD Assay Development team, requiring strong multidisciplinary skills from technical to communication.
Job performance will involve a variety of activities including:
- Design studies, guide study execution, conduct analysis, and write reports for assay development, verification, and validation.
- Lead a team of research associates and scientists to conduct studies, analysis, and reporting in support of assay development and design control within accepted timelines, budgets, and resource availability.
- Generate scientific content in support of regulatory submissions.
- Generate design control documentation including user needs and design inputs, design and development plans, verification and validation plans/protocols/reports, and phase review materials.
- Responsible for stakeholder communications and presentation of study results.
- Participate in cross-functional project planning and serve as a Subject Matter Expert for Clinical Operations, Quality Control, and Manufacturing.
- 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.
- 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
- Thoughtful and decisive team leader
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward
- Clear, accurate, honest
- 5+ years of laboratory experience (required)
- 4+ years in an IVD/CDx industry setting (highly preferred)
- Familiarity with IVD and CDx guidelines from FDA, CLSI, etc. (required)
- Proficiency in PCR, qPCR, and molecular genetic techniques (required)
- Familiarity with NGS and bioinformatics (required)
- Familiarity with statistical analyses (required)
- Familiarity with R, python, or other coding languages (required)
- Familiarity with principles of design control (required)
- Expertise in authoring and presenting scientific content (required)
- BA/BS, MA/MS, or PhD in biochemistry or related field and/or equivalent combination of education and experience
- This position supervises junior team members to complete complex tasks.
- This position operates in a professional office environment.
- The job requires an individual to routinely use standard office equipment such as computers, phones, and photocopiers.
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 10 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 $119,325. 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.