Manufacturing Associate I/II, GMP NGS

Company: Gritstone Oncology, Inc.
Location: Cambridge
Posted on: April 6, 2021

Job Description:

The primary role of the Manufacturing Associate is to be responsible for the execution of established histology, and next-generation sequencing assays in the GMP Next Generation Sequencing (NGS) laboratory. This team is responsible for the GMP compliant processing of cancer patient samples through nucleic acid extraction and next generation sequencing. The ideal candidate will have patient-centric approach and experience in a regulated environment (CLIA/CAP, cGMP) and will be expected to maintain batch record reports, consumable inventory, equipment maintenance and calibration to maintain quality control and compliance. Individuals with experience as a Clinical Lab Technologist or Molecular Technologist are encouraged to apply. Requirements * Ability to work either Monday through Friday or Tuesday through Saturday as needed for patient processing. Minimum Education/Experience * Bachelor's degree (or equivalent) in scientific discipline or a health-related field* 2+ years relevant experience, including in a regulated setting (title can be adjusted based on level of experience) Other Qualifications * Strong background in molecular biology and associated general laboratory techniques (PCR, qPCR, nucleic acid purification, Next Gen Sequencing)* Histology experience (microtome operation and FFPE sectioning)* Familiarity with NGS workflows including nucleic acid extraction from various tissue specimens (cell line, blood, fresh frozen and FFPE), Illumina-based library construction, and hybrid capture enrichment* Operation and maintenance of instrumentation critical for Illumina NGS workflows (qPCR, plate readers and HiSeq/MiSeq/NovaSeq sequencers)* CLIA/CAP or cGMP experience* Experience working with automated liquid handling* Experience with LIMS* Experience working with Quality Assurance and Quality Control teams* Impeccable documentation practices and attention to detail* Maintaining cleanliness and orderliness of operational area.* The ability to prioritize and complete tasks in a timely manner* Excellent written and verbal communication skills* A willingness to work hard in a fast-paced environment Knowledge and Skills * Patient-centric approach - Ensure that high quality results are generated for our patients in a timely manner.* Teamwork - Ability to work well in a highly cross-functional team environment. Eagerness to excel and have a positive approach.* Communication - Able to expresses one's self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor* Analytical Skills - Detail oriented, able to follow written procedures and document results.* Organization - Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously* Motivated - Self-motivated and willing to accept temporary responsibilities outside of initial job description.

Keywords: Gritstone Oncology, Inc., Cambridge , Manufacturing Associate I/II, GMP NGS, Other , Cambridge, Massachusetts