Sr. Reagent Associate at Personalis | Powderkeg

Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The [Personalis NeXT Platform]( next-platform%2F&esheet=52534858&newsitemid=20211118006333&lan=en- US&anchor=Personalis+NeXT+Platform&index=2&md5=994af974cf5c973f890d0bc5a72ef63b)® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' [Clinical Laboratory]( US&anchor=Clinical+Laboratory&index=3&md5=214191f02a8e211e8a6037256ce4a478) was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists- accredited.


Personalis is seeking a Senior Reagent Associate skilled in the practical and technical execution of qualification, formulation/aliquoting and QC activities associated with NGS reagents as part of a small operations team in a complex and dynamic clinical laboratory environment. In this role, you will be a key participant within the team and collaborate cross-functionally with members of process development, quality, automation, and operations in the implementation and execution of large variety of complex, sensitive reagents with a high level of quality and compliance.

  • Formulate/aliquot and qualify complex reagents and document according to approved procedures using Good Documentation Practices (GDP)
  • Perform LIMS entry for released batches of reagents for use in the RUO/CGLP/Clinical Operations laboratories
  • Manage inventory of materials and reagents by assessing the results of the inventory counts and recommending appropriate lot sizes and scheduling for replenishment
  • Perform and document qualification activities of incoming raw materials and reagents according to approved procedures using GDP
  • Create and revise reagent batch records, associated SOPs, inspection records and QC specifications
  • Participates in the tech transfer activities of new reagents across instrument platforms, workflows and compliance levels
  • Identify and execute the continuous improvement activities of existing reagents and associated processes
  • Apply company policies and procedures to ensure compliance, identify, investigate, and escalate and resolve issues related to reagents and associated processes to supervisor
  • Support the upkeep, orderliness, and cleanliness of the reagent laboratory and equipment maintenance
  • Other responsibilities, as applicable.

**Qualifications: **

  • Bachelor's in biology, biochemistry, molecular biology or related field and 5+ years of relevant laboratory experience.
  • Solid foundation in molecular biology techniques, with preferred experience in the areas of sample prep and analysis related to NGS. Knowledge of genomics is desirable.
  • Experience as a bench scientist in an operations, development, or quality control laboratory environment, with lab automation system experience a plus.
  • Proficiency in Microsoft Office, with additional experience with LIMS, PLM and/or ERP preferred.
  • Previous GLP, GMP, and/or GCLP laboratory work experience required, with additional experience with regulatory and quality practices (CAP/CLIA, ISO13485, FDA) preferable
  • Ability to communicate effectively (written and verbal) communication skills, detail oriented and adaptable

_Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package. _


Job Summary
  • Job Title
    Sr. Reagent Associate
  • Company
  • Location
    Menlo Park, CA
  • Employment Type
    Full time
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