Sr. Manager, Biomaterials Repository

1 month ago
Job ID
2017-5076
US
Category
Laboratory Operations
CA
Redwood City

Overview

Genomic Health currently has an exciting opportunity in the Biomaterials Repository facility (BMR). The BMR is dedicated to collecting, banking and processing human tissue for Research and Development (R&D) activities ranging from proof-of-concept experiments to clinical studies. You will management of the daily functions of the team. He or she will collaborate with his/her manager and internal partner groups for continuous process improvement to meet future company needs. He or she will partner with study teams and external collaborators to ensure successful delivery of study activities and will participate in audits/inspections as required. This position requires regulatory experience. Contract research organization (CRO) laboratory experience is preferred. This person will have strong communication, organizational skills and project management process experience. You should be knowledgeable about kits, supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, immunohistochemistry (IHC), digital pathology and anatomic & clinical pathology. He or she will have experienced knowledge of tissue handling, tumor tissue sectioning, and biosafety protocols. You'll have the ability to work productively in cross-functional groups.

 

You should have a degree in biological sciences and/or a related clinical license.

Responsibilities

  • Lead people management activities including hiring, goal setting, skill training, mentoring and staff development
  • Assign and supervise the day-to-day activities of the BMR and of the BMR staff
  • Identify, implement, and manage workflows and protocols needed to meet regulatory requirements
  • Partner with internal and external collaborators to ensure successful delivery of study activities
  • Responsible for the delivery of annotated samples to client groups
  • Partner in external and internal audits/inspections as required
  • Ensure tasks and process steps are completed within established protocols, specifications and timelines
  • Manage sample accessioning process for studies: kits, supplies, logistics, laboratory operations, specimen storage, initial quality assessments, data reporting and transfers, and collecting all relevant data
  • Maintain physical inventory of all R&D biomaterials
  • Supervise all specimen transactions into and out of the BMR, ensuring proper sign-off for all material requests
  • Manage H&E and immunohistochemical (IHC) slide processing, digital pathology scanning, image storage, utilization of image analysis software
  • Work with Pathology to perform IHC staining process optimization and validation utilizing automated IHC platforms
  • Identify and evaluate process improvement opportunities
  • Develop and maintain good working relationships with internal and external clients
  • Assist in communication of issues/risks to key partners
  • Attend and when appropriate lead cross-functional working group and study team meetings
  • Test new protocols and equipment (tissue processing, alternate storage methods, image analysis scanners, LCM platforms, IHC and immunofluorescence, etc.)
  • Work with the supervising Pathologist in the build-out of the Biomaterials Core facility as needed
  • Direct hands on biomaterials processing, including routine sectioning of paraffin embedded tumor tissue blocks, receipt and accessioning of liquid specimens (blood, urine)
  • Plan laboratory schedules to support clinical studies, including work schedules and equipment usage
  • Supervise and implement pilot studies in the BMR to support R&D

Qualifications

  • BS with biological science emphasis or equivalent experience
  • 5 or more years of professional experience in FDA regulated environments
  • 5+ years of work experience in a CRO, tissue bank, or related functional area
  • 3+ years of experience of successfully leading a team, projects, and processes
  • Strong communicator with an attested ability to maintain open and productive communication with internal employees, managers and customers as needed
  • Experience working in a regulated environment/expertise with regulatory protocols
  • Desire to set clear goals and mentor staff while building leadership and management skills
  • Experience both supervising staff and completing direct hands-on duties simultaneously is desired
  • Consistent record of leadership, reliability and desire to work independently when necessary
  • Proficiency with database systems, computer literacy, digital pathology, image analysis, IHC, and graphic software a plus
  • Work experience with relational databases and the SQL language is a plus
  • Strong analytical, problem solving and decision-making skills, especially when limited and incomplete information is available. Seeks help when necessary and helps bring focus and clarity when ambiguity arises.
  • Strong listening, verbal and written communication skills among technical and non-technical personnel
  • Able to integrate and apply feedback in a professional manner
  • Able to prioritize and commitment to results with a high emphasis on quality
  • Collaborate as part of a team

Travel, Physical/Mental Demands and Work Environment

- Standing or sitting for long periods of time may be necessary
- Some lifting (up to 15 pounds) may be necessary.
- Considerable amount of time using various types of laboratory equipment including microscopes, microtomes, blades, strainers, pipettes
- May perform repetitious actions using lab tools
- Some time spent using near vision to view samples at close range
- Use of various chemicals may be used to perform duties
- At times, stress may be experienced
- Use of computer and some time may be spent concentrating, reading, or analyzing data, or applying scientific rules
- Exposure to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation

Company Profile

Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer, one of the greatest issues in healthcare today. With its Oncotype IQ™ Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 600,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.

 

Join the Genomic Health Team, and have the unique opportunity to make a difference in the lives of patients with cancer, while developing your career potential.  We value our employees and consider them an integral part of our company’s growth and success. We maintain competitive total rewards programs designed to satisfy our employees’ work life and personal life needs.  To learn more about careers at Genomic Health visit: http://www.genomichealth.com/join_our_team

 

All qualified applicants will receive consideration for employment without regard to race, sex, gender identity, color, religion, national origin, protected veteran status, or on the basis of disability.

 

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