Reporting to the VP of Operations, the Associate Director, Reagent Quality will lead our Reagent Quality team, with primary accountability for ensuring the consistent quality of reagents and plastic consumables used by Genomic Health's Clinical Laboratory to deliver Oncotype DX results to cancer patients to inform their decisions regarding treatment options. He or she will oversee the Reagent Quality team's efforts in the development of analytical and functional quality control test methods and release specifications as well as the team's ongoing use of these methods for QC testing of reagent lots, stability studies, and investigation of reagent quality issues.
The successful candidate will provide leadership in the development and ongoing refinement of quality control infrastructure for new Genomic Health products, driving continual improvement in multiple areas including the efficiency of QC workflows, the capability of QC data systems for efficient long-term monitoring of reagent quality data, and the effectiveness of the QC methods themselves for ensuring consistent control over our commercial patient sample testing processes. He or she will also contribute to cross-functional teams developing new products and improved processes for existing products, providing technical leadership in the chemistry of our assays and identifying opportunities for reducing the variability of our assays through stringent control of their chemistry. He or she will have primary accountability for the creation and implementation of the required test methods, stability data, and the associated study protocols, reports, and standard operating procedures which ensure that quality issues with reagent or consumable lots are discovered and addressed prior to their use in our Clinical Laboratory.
This Associate Director will be responsible for maintaining the required capacity for the ongoing release of reagent lots supplied to our Clinical Laboratory and Genomic Sciences (R&D) Laboratory, anticipating well in advance the need for additional staffing, equipment, and space. He or she will identify bottlenecks, propose and champion process improvements in reagent QC testing processes, and collaborate with Process Engineering, Genomic Sciences, Quality, Biostatistics, and other appropriate functions to implement them.
The successful candidate will continue to build a cohesive Reagent Quality team, fostering effective collaboration with other functional areas across Operations, Genomic Sciences, and other areas. He or she will continuously develop the team's capabilities, providing technical leadership in the development and validation of rigorous analytical methods using HPLC, enzyme activity assays, spectrophotometry, and other analytical test methods in addition to functional test methods based on RT-PCR, DNA sequencing, and other technologies used in our genomic assays. Collaborating with Biostatistics, he or she will mentor the team in statistical methods for data analysis and experimental design while continuing to build the group's capabilities for authoring SOPs, other process documentation, experimental protocols, and study reports.
Lead the Reagent Quality team with direct management responsibilities including hiring, goal setting, professional development, mentoring, and training.
Identify and champion opportunities to develop, validate, and implement quality control test methods for reagents and plastic consumables to reduce variability of genomic assays used for commercial patient sample testing and in clinical development studies
Partner with Genomic Sciences, Biostatistics, and other functions on the development and use of appropriate test methods for characterizing the composition, functional performance, and stability of reagents and consumables required for the development and launch of new products
Oversee the rigorous development, validation, and implementation of new quality control tests for reagents and consumables, including analytical tests designed to assess their chemical and physical properties and functional tests designed to assess their performance characteristics in their intended uses
Ensure consistent compliance with applicable federal, state, and local regulations and quality-related best practices in development, validation, use, and documentation of analytical and functional test methods for reagent lot qualification, stability studies, and related activities
Lead the investigation and resolution of reagent / consumable-related issues with our laboratory processes (e.g. investigating special cause variation, changes in failure or repeat rates, other unusual behavior of reagents, consumables, or data), including assessment of impact, root cause identification, and appropriate corrective and preventive action
Provide technical leadership within cross-functional teams for the exploration, development, and validation of improvements in the chemistry of our commercial assays to achieve gains in analytical performance, cost, and efficiency
Ensure efficiency, effectiveness, and scalability in our quality control testing processes for purchased and internally manufactured reagents, carefully balancing the cost, effort, and complexity of QC testing processes with the magnitude of the risks being mitigated by these test methods and driving continual improvement in the overall testing and release process and documentation
Anticipate and plan for the required staffing, equipment, and other resources required for ongoing QC testing of reagents and consumables, development of required QC test methods, and other projects based on forecasted purchasing and internal manufacturing of reagent lots, product and process development project timelines, and other relevant factors
Provide technical leadership in the management of our critical suppliers, collaborating closely with colleagues in Quality, Supply Chain Management, Biostatistics, Process Engineering, R&D, and other functions to address and prevent supplier quality issues; facilitate collaborative resolution of issues by effectively communicating specific quality concerns to suppliers and collaborating with them to address the root cause
Collaborate with Biostatistics and Quality to trend QC testing data on key reagents and consumables over time to provide insight into supplier process capabilities and detect indications of special cause variation in incoming lots; lead the development of new reporting tools for this purpose as necessary.
- A Ph.D. or M.S. in Chemistry or Biochemistry and at least eight years of relevant industrial experience are required.
- A track record of success in managing the development and ongoing use of analytical and functional test methods for reagents used in RT-PCR, DNA sequencing, and related genomic analysis methods, preferably in an in-vitro diagnostics, pharmaceutical, or medical device company, including extensive experience with design and documentation of method development and validation studies, and with documentation and transfer of these methods to Quality Control staff in clear, concise SOP's in support of regulatory filings and/or product launches is also required.
- Experience with a proven track record of hiring and development of staff and building successful teams
- Broad expertise with a wide range of spectroscopic, chromatographic, and other analytical tools for the analysis of proteins, nucleic acids, and small molecules as well as expertise in the use of statistical methods for data analysis and experimental design in a regulated environment is highly desirable.
- Excellent communication, collaboration, individual staff development, and leadership skills coupled with a strong desire to work in a dynamic interdisciplinary team environment are essential.
- Additional requirements include the ability to integrate and apply feedback in a professional manner and prioritize and drive to results with a high emphasis on quality.
An in-depth understanding of the reagent formulations used RT-PCR and DNA sequencing, including their critical components, the processes used to manufacture and test these components and final formulations, and the biochemistry of the critical enzymes, oligonucleotides, and other key components used in these applications is highly desirable.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
Travel Requirements: Minimal (Less than 10% Travel).
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