This experienced Analytical Chemistry leader will manage our Analytical Sciences team, which is responsible for ensuring the quality of reagents used in Genomic Health's Clinical Laboratory for patient sample testing. He or she will oversee the Analytical Sciences team's efforts in the development of reagent 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. He or she will also contribute to cross-functional teams developing new products and improved processes for existing products, with primary accountability for the creation of the required test methods, stability data, and the associated study protocols, reports, and standard operating procedures. Through these efforts, the successful candidate will make critical contributions to the scalability and agility of our laboratory operations.
This Senior Manager will be responsible for ensuring that the Reagent QC function within Analytical Sciences has the required capacity for the ongoing release of reagent lots supplied to our Clinical Laboratory and Development Laboratory, anticipating well in advance the need for additional staffing, equipment, and space as well as process improvements capable of adding capacity with existing resources. He or she will identify bottlenecks, propose and champion process improvements in reagent QC testing processes, and collaborate with Process Engineering, Quality Assurance, Biostatistics, and other appropriate functions to implement them.
The successful candidate will continue to build a cohesive and collaborative Analytical Sciences team, while developing their depth and breadth of capabilities, providing technical expertise in the development and validation of rigorous analytical methods using HPLC, enzyme activity assays, spectrophotometry, and a broad range of other analytical methods. 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.
- 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 an Analytical Chemistry function, 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.
- 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 is essential.
- A strong understanding of quantitative RT-PCR chemistry, DNA sequencing chemistry, and the methods for the analytical characterization of the critical enzymes and oligonucleotides used therein 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.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Travel Requirements: Minimal (Less than 10% Travel).
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation.
- Repetitive manual pipetting may be necessary.
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