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Associate Director, Translational Pathology Biomarker Testing Lab Operation

Employer
NewYorkLifeScience.com
Location
Bothell, WA
Closing date
Aug 9, 2022

View more

Sector
Doctors, Pathology, Pharmaceutical, Laboratory
Organization Type
Corporate
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Associate Director, Translational Pathology Biomarker Testing Lab Operation
Development - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen's dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

Seagen is seeking an Associate Director, Translational Pathology Biomarker Testing Laboratory (TPBTL) Operations to join the Clinical Biomarker and Diagnostics (CBDx) Team within the Translational Sciences organization, which functions to generate, implement, and execute biomarker strategies for Seagen's drug programs that have progressed to clinical development. CBDx collaborates cross-functionally with other areas of Seagen as well as with external partners to achieve goals that are critical for drug development.

The Associate Director, Translational Pathology Biomarker Testing Laboratory (TPBTL) Operations will play a key role in establishing the newly built TPBTL, building a high performing team, readying the new TPBTL, the development of the Quality Manual and SOPs and policies, and applying for and securing Washington State and CLIA (via Washington State, which is a CLIA exempt state) certification and CAP accreditation.

Within the CBDX structure, this role will oversee laboratory operations for the TPBTL, from sample receipt through analysis and reporting for clinical and pharmaceutical research services. The role will directly manage and help build a high-performing team, including the TPBTL Biosample Management Team, TPBTL Histotechnician(s), TPBTL Molecular technician(s), and the TPBTL Data Integration Team.

This position will collaborate with the Sr. Manager, Translational Pathology Laboratories, and other TPBTL staff to integrate the TPBTL within the Core Translational Pathology Laboratories, and to expand the laboratory and technologies over time. Further (s)he/they will work within Translational Science, and with Research and Development on Assay Transfer and Robust Prototype Assay Development and testing, and reporting of consented human tissue samples for exploratory research and clinical trial purposes using validated Immunohistochemical, In-situ Hybridization, Next Gen Sequencing and other assays on qualified technology platforms.

Responsibilities:

Oversees laboratory operations for the TP Biomarker Testing Lab, from sample receipt through analysis and reporting for clinical and pharmaceutical research services. Directly manages the TPBTL Biosample Management Team, TPBTL Histotechnician(s), TPBTL Molecular technician(s), and the TPBTL Data Integration Team.
  • Oversee management of TPBTL Operations and staff
  • Oversee testing with validated Immunohistochemical, In-situ Hybridization, Next Gen Sequencing, and other assays on qualified technology platforms
  • Work with lab management to identify and implement optimal structure and core processes for laboratory and analysis operations
  • Provide technical direction as needed
  • Participate in laboratory budget planning
  • Monitor laboratory and administrative action plans to address identified deficiencies
  • Establish sample processing priorities and maintain TAT metrics for clinical and research projects
  • Ensure the laboratory meets all quality and regulatory requirements for Washington State, CLIA, and CAP as well as internal customers
  • Drive continuous measurable improvement in laboratory quality and productivity
  • Ensure appropriate calibration, and maintenance of all laboratory instruments
  • Ensure all relevant documentation for the laboratory
  • Develop new laboratory SOPs as appropriate to ensure the laboratory meets consistent quality and productivity goals
  • Develop requirements for laboratory improvements and/or expansion
  • Evaluate new technology, automation, and methods for continuous process improvement
  • Expand the TPBTL laboratory and technology over time
  • Generate quality reports for all aspects of laboratory testing
  • Assist in the review of quotes, assist programs with specimen and documentation requirements
  • Assist with capacity modeling
  • Work with IT to drive ongoing LIMS improvements and automation efforts
  • Manage oversight of sample inventory and retention policies
  • Contribute as a laboratory testing SME across the company
  • Assist Quality Department with licensure applications, renewals, and inspections
  • Assist Quality Department with audit preparation and follow-up
  • Assist Quality Department with CAPA investigation and resolution
  • Maintain a robust competency program for assessment of technologist competency
  • Ensure successful participation in Laboratory Proficiency Testing programs and efforts
  • Assure adequate method verification and validation is performed for accuracy and precision
  • Assure all test systems are performing within established quality limits
  • Ensure that supplies are stocked to meet testing needs
  • Maintain laboratory staff by recruiting, selecting, orienting, and training employees
  • Manage and develop employees to achieve business area and employee goals
  • Take remedial action when test systems deviate from established performance criteria

Required Qualifications:
  • Doctoral degree in clinical laboratory science or chemical, physical, or biological science with 1 year training and experience in high-complexity testing OR
  • Master's degree in clinical laboratory science, medical technology, or chemical, physical, or biological science with 1 year training and experience in high-complexity testing
  • Subsequent to graduation has had at least 4 years of pertinent full-time laboratory experience of which not less than 2 years have been spent working in an Anatomic Pathology and/or Molecular Pathology Laboratory

Preferred Qualifications:
  • Doctorate PhD highly preferred.
  • Masters degree in Biological Sciences AND 10 years of laboratory experience preferred.
  • 6 years of management in a CAP/CLIA GCLP laboratory with IHC and NGS preferred.
  • Oncology clinical diagnostic experience highly preferred.

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

NewYorkLifeScience.com, owned and published by Info.Resource, Inc. ,is a resource
for the life science industry in the state of New York.
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