Sr Scientist, Reagent QC Development

CareDx is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

As the Sr Scientist, Reagent QC Development, you will make significant contributions to the Manufacturing, Process Development & Process Engineering Team in supporting all of Operations as it relates to the quality control of reagents used by the CareDx CLIA Laboratory in the processing of patient samples through the workflow. Using your scientific expertise, responsibilities include reagent characterization, refining existing QC methods, development of new QC methods and specifications, technical troubleshooting, complex data analysis, and process validation. Scope includes incoming inspection of raw materials through final QC of finished goods, including the evaluation and potential re-qualification of new vendors. Primary objective is to improve the overall quality, cost, efficiency, and reliability of our reagents to minimize any risk to patient testing. The successful candidate will become the recognized subject matter expert in the department to support the QC of reagent materials used in our assays, and to be a major contributor to the optimization of reagent QC as it relates to processes, technologies, data analysis tools and systems. Additional responsibilities may extend to other aspects of reagent manufacturing, including design transfer, stability testing and workflow optimization. This position will be highly cross functional, working closely with Manufacturing, R&D, Quality, CLIA, Supply Chain, Automation and Process Engineering. We are looking for a meticulous and dedicated candidate with assay development experience and willingness to perform hands-on bench work, as necessary, to perform testing and development activities in the lab.

Responsibilities as follows, but not necessarily limited to:

• Process development and validation activities, including designing and executing test protocols, gage R&R and/or guardbanding studies, developing QC methods and specifications, writing up technical documentation including work instructions, batch records, specification documents, and reports, and transfer, including training of Operations personnel.
• Performing risk assessment to prioritize improvement areas and needs as it relates to quality and availability of reagents for patient testing. Will include comprehensive review of existing QC test methods and strategies for reagents across Manufacturing and CLIA, including an assessment of analytical vs functional QC methods.
• Establishing control charts and performing routine process monitoring to ensure that developed methods and released reagents meet CareDx's quality standards. Work in collaboration with the CLIA Laboratory to investigate and address any quality or performance issues.
• Lead complex technical troubleshooting efforts related to production or QC processes, technology transfer, and critical component issues for real-time PCR and Next-Generation Sequencing processes. May require investigation into process failures, reagents or consumables, and/or equipment/instrumentation.
  • Responsible for initiating incident or deviation reports, as necessary, and performing the analysis, and providing justification and/or recommendations for course of action.
• Summarize, tabulate and analyze data relevant to a range of protocols or routine production data, incorporating statistical analysis and visual analytics as necessary. Be able to present findings and recommendations effectively to broad audiences ranging from executive management to external collaborators, either through the submission of reports, conducting oral presentations, or leading design reviews.
• Apply technical rigor and scientific oversight for the development, validation and transfer of new or improved QC/production methods for tests involving PCR, NGS, and other molecular approaches.
• Provide mentoring and technical guidance to junior scientists and Manufacturing personnel on understanding of experimental design, execution of test plans, interpretation of results, and scientific theory.
• Drive ongoing Operational Excellence initiatives and process optimization of Operations to facilitate continuous improvement on key performance indicators/metrics.
  • Responsible for any documentation or engineering changes required. Able to initiate change management requests or CAPA's as necessary to drive process change or improvementsWork closely with Process
• Engineering, Transfer Team, Software Development, Automation Engineering, Statistics, Bioinformatics, and R&D functions in the design, development and analysis of software tools, analytical methods, validation and test plans. Scope of responsibilities may extend outside of immediate work area.
• Work collaboratively with R&D to ensure soundness of verification and validation of new or redesigned QC methodologies, manufacturing systems or processes.
• Stay up to date with current scientific principles, theories, and methodologies, including technology and instrumentation to contribute to the continuous improvement of QC methods and spscification. May be required to contribute to scientific presentations, literature, and conferences.
• Keep complete and accurate records. Adhere to and document all aspects of design control and cGMP activities.

Qualifications:

• Education: BA/MS (Biochemistry, Chemistry, Molecular Biology or a related scientific discipline) and 5 - 10 years of relevant industry experience.
• Minimum of 5 years' experience in assay development, reagent manufacturing support or technology transfer positions in the clinical diagnostic or life science industry.
• Extensive industrial experience in technical troubleshooting, process optimization, transfer and validation of molecular biology-based lab processes and reagents. Hands-on experience with the qualification, formulation, handling and processing of oligo and enzyme-based reagents and principles of biological processes (PCR, sequencing, etc.).
• Experience working in a CLIA/FDA regulated environment. Strong understanding of QMS, GDP and design control.
• Background in automation, robotics, lab instrumentation and analytical equipment. Extensive experience with real-time PCR and NGS instruments.
• Experience with LIS, electronic document controls systems, and databases.
• Experience with visual analytics software such as Tableau.
• Strong understanding, experience with, and utilization of statistical methods for the analysis and troubleshooting of molecular diagnostic assays.
• Demonstrated expertise in resolution of mission-critical technical challenges in manufacturing and process improvement.
• Works independently and demonstrates initiative and strong task leadership with timely achievement of goals critical to organizational success.
• Strong collaborative nature, with ability to lead cross-functional stakeholders to ensure successful execution of corporate objectives.
• Sound judgment and ability to provide recommended course of action based on the presentation of data evidence and justification.
• Strong interpersonal skills and high communication proficiency both verbal and written, in technical and non-technical domains.
• Ability to serve as primary contact for the department for external contacts, such as vendors or service providers, and in inter-site interactions/communications.
• Excellent analytical and problem-solving skills, with the ability to work effectively with large data sets.
• Excellent record keeping and organizational skills.

Additional Details:

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• Pre-tax commuter benefits
• And more!

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it's an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.

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