Manufacturing Associate I/II, GMP NGS
Company: Gritstone Oncology, Inc.
Location: Cambridge
Posted on: April 6, 2021
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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
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