Genomics Senior Technology Development Scientist

Here, it's different. Come join us.

Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years.

Here, the nation's brightest nurses, physicians, scientists, researchers, therapists, and care providers are creating the future of child health. With an optimist's outlook, a trailblazing spirit, and a celebrated history, we're making new strides every day.

We've been Magnet-designated four times by the American Nurses Credentialing Center and are consistently recognized among the best of the best pediatric hospitals with #1 rankings in Colorado and the region by U.S. News & World Report.

As a national leader in pediatric care, we serve children and families from all over the nation. Our System of Care includes four pediatric hospitals, 11 specialty care centers, 1,300+ outreach clinics and more than 10,000 healthcare professionals representing the full spectrum of pediatric care specialties.

Here, we know it takes all of us, every role, to deliver the best possible care to each child and family we treat.

That's why we build our teams toward a foundation of equity in access, advancement, and opportunity. We know teams of individuals with different identities and backgrounds can nurture creativity and innovation. We know we can see, treat, and heal children better when our team reflects the diversity of our patient population. We strive to attract and retain diverse talent because we know a truly inclusive and equitable workforce will help us one day realize our most basic calling: to heal every child who comes through our doors.

A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Here, it's different.

The Genomics Senior Technology Development Scientist is an integral part of the Children's Hospital Colorado Precision Diagnostics Laboratory team. The Senior Technology Development Scientist, with input from Scientific, technical, and clinical leaders, works in collaboration with others on one or more projects which are complex in scope. The Sr Technology Development Scientist participates in or leads planning of projects and experiments and is often the technical lead responsible for the successful execution of the project. This position involves independently making detailed observations, analyzing data, interpreting results, and providing insights into the next steps and direction of the project, as well as independently determining methods and procedures on new assignments or projects.

Working in a team setting, the Senior Technology Development Scientist will be involved in technology development projects in exploring and researching new technologies, providing ideas and concepts to improve or develop processes, and/or establish methods and processes for technology development of clinical diagnostic assays. This position may also mentor and provide technical guidance to junior scientists in project teams however routine execution of wet lab experiments is expected.

The successful candidate will support and execute the technology development of NGS-based methods to improve clinical diagnostic assays performance for patients with cancer or rare disease. Responsibilities of this position include design, execution, and optimization of innovative NGS-based solutions that integrate clinical assay requirements with analytical and operational performance. This role will require deep understanding of NGS sample preparation and data analysis to collaboratively develop new workflows for the highly accurate detection of germline or somatic genomic changes in clinical laboratory.

The Clinical Scientist is responsible for the development of new assays, tests and kits. Works closely with laboratory leaders and consults with clinical and technical experts to identify unmet needs for new tests and improved methodology.

This position may have the following additional job functions:

• Develop technology development plans and experimental outlines to write experimental protocols and perform laboratory experiments. Prepare detailed technical procedures, protocols, and reports.
• Independently develop and conduct bench level experiments within several technology areas and identify problems and discrepancies.
• Independently develop, plan, analyze and interpret results of bench level experiments within several technology areas; effectively present and clearly communicate findings project team meetings. Prepare reports and documentation highly technical analysis or summarization of experimental results. Provide insights into the next steps.
• Evaluate and identify nonconforming data and address trends for process improvement.
• Provide technical guidance to junior scientists.
• Operate scientific instrumentation according to clinical regulatory guidelines and notify appropriate personnel of any problems.
• Effectively determine, utilize, and apply methods or technologies and provide ideas for new techniques, when appropriate.
• Maintain knowledge of technological industry developments that could assist in completion of an assignment or aid in the development of new processes or procedures.
• Provide technical leadership and participate in decisions affecting project planning and experimental design.
• Prepare and provide information and data for scientific literature and publications.
• Generate, document, and communicate development plans for critical aspects of a project. Maintain clear laboratory documentation in a complete and consistent manner to comply with regulatory bodies.
• Work on problems which are extremely complex in scope in which analysis of data requires an evaluation of intangible variables.
• Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining solutions.
• Work on individual assignments and with project team members, as appropriate, to meet department and project objectives.
• Work within project timeframes with successful outcomes on multiple projects and key responsibilities.
• Act as subject matter expert in team and/or cross-functional meetings.
• Support and comply with the company's Quality Management System policies and procedures.

Department: Precision Diagnostics PDX Lab

Hours per week: 40, eligible for benefits

Shift: Monday - Friday, 8am - 5pm, work hours may vary based on the needs of the department. With the potential to support weekend and holiday staffing hours as needed.

*This is a hybrid role.

EDUCATION - PHD in a chemical, physical, biological or directly related science.
EXPERIENCE - Completion of a formal fellowship training program or 3 years of relevant laboratory experience at the PhD level.
CERTIFICATION(S) - Board Certification preferred.

Preferred Qualifications

• 6+ years of industry or academic research experience in Life Sciences, Chemistry, or related field.
• 3+ years of experience in medical device/IVD, biotech, life science or pharmaceutical industry.
• Experience in a biotech or product development/manufacturing environment.
• Experience with genomic databases and related software.
• Previous experience working in a molecular diagnostics/clinical laboratory setting.
• Deep understanding of the practices and principles of NGS including molecular biology and data analysis based upon extensive hands-on experience with the development, optimization and troubleshooting of NGS-based workflows for DNA and RNA from clinical samples.
• Extensive experience with interpretation and analysis of NGS data using external and in-house computational methods to support method development and characterization of genomic and epigenomic biomarkers associated with cancer.
• Experience with product development for use in an LDT- or FDA-regulated environment including designing analytical validation studies

POPULATION SPECIFIC CARE

No direct patient care.

ESSENTIAL FUNCTIONS
An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform.

• Provides technical expertise to programs, processes, and best practices. Assists in the training of technical staff during and after the implementation of new assays.
• Analyzes raw data and assists in preparation of reports for final review and medical director approval.
• Reviews test results and interprets laboratory test reports, as appropriate.
• May act as a variant analyst for classification of observed variants or unusual or unexpected results. Organizes, coordinates, and may perform activities for new assay development; developing assays as required by the laboratory and ensures that assays are developed in good laboratory practice, are consistent with regulatory requirements and relevant DPLM policies and procedures.
• Works on highly complex or controversial projects; performs project management activities.
• Partners with operational counterpart to establish a culture of openness, continuous quality improvement and staff engagement.
• Participates in budget process, cost analysis of new or ongoing clinical testing, and makes recommendations to improve testing efficiency, reagents and supply chain costs.
• Participates in strategic planning process, annual goals, and performance metrics for laboratory; participates in the implementation of plans for aligning function(s) to operational vision and strategy
• Participates in leadership activities for the operation, contributing to the achievement of goals and objectives; evaluates functional performance. Participates in identifying and implementing process improvements including the documentation of performance and quality statistics.
• Knowledgeable of and supports federal, state, and local regulatory compliance for functional area(s).
• Regularly assesses the market need for testing and assures that new test methods meet the needs of patients. Meets with key stakeholder to discuss potential new market areas.
• Supports customer service standards established by leaders.
• Supports collaborations with potential partners to enhance nonpatient revenue.
• Supports potential clinical research protocols and potential industry sponsored clinical studies.
• Presents scientific and educational seminars to staff and colleagues. Serves as an interface between medical staff and technical staff

SCOPE AND LEVEL

Guidelines: Advanced full performance professional level work that requires additional knowledge, education, training or experience. Guidelines are generally in the form of stated objectives only with issues and factors largely undefined requiring the employee to exercise creativity and ingenuity in devising criteria, techniques, strategy, and methodologies for approaching assigned functions or projects.

Complexity: Duties performed involve concepts, theories, and concrete factors to be evaluated and weighed requiring a high degree of analytical ability, independent judgment, and decision-making. Acts as a subject matter expert in the field of expertise.

Decision Making: Exercises judgment and discretion, and is responsible for determining the time, place and sequence of the work performed.

Communication: Contacts with team members, clients or the public where some degree of discretion and judgment are required in carrying out a major program and/or function of the organization.

Supervision Received: Performs work with minimal supervisory oversight. Work assignment is generally unstructured and employee is responsible for organizing complex, varied, and simultaneous coordination of several functions, programs, or projects in various stages of completion.

Work Environment

• Equipment: telephone, computers, reading reports/graphs
• Exposure: Exposure to blood/body fluid: Occasional.
• Exposure: Exposure to chemicals: Occasional.
• Exposure: Exposure to infectious diseases: Frequent.
• Mental and Emotional Requirements: Independent discretion/decision making.
• Mental and Emotional Requirements: Makes decisions under pressure.
• Mental and Emotional Requirements: Manages stress appropriately.
• Mental and Emotional Stress: Managing workload and system issues
• Mental Stress: multi-tasking, meeting deadlines, prioritizing

It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information.

The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.

Here, you matter. As a Children's Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.

Children's Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.