Senior Scientist Clinical Biomarker and Companion Diagnostics


Houston, Texas, United States of America

Job Description

Job Title: Senior Scientist
Clinical Biomarker and Companion Diagnostics

Responsible
to: Chief Scientific Officer

Role

To
lead the development of clinical biomarkers and companion diagnostics for
engineered T and NKT cells to treat human cancers. The appropriate candidate
must possess a deep understanding of clinical biomarker development and the
regulatory guidelines for companion diagnostic submissions. While the primary
role of this position will focus on the development of assays for patient
selection, this role will also provide pivotal hands-on scientific input and
experience to drive research efforts leading to the understanding of
pre-clinical and clinical efficacy for early and late stage clinical trials.
This position will be required to interact with clinical and research teams to
support product development into and through the clinic.

Responsibilities

We
are seeking a Scientist/Senior Scientist to join the R&D group within Cell
Medica at the Houston, TX site. The successful candidate will have in-depth
expertise in companion diagnostics and clinical biomarker development and their
application for cellular immunotherapies. The purpose of this position is to
provide hands-on experience from strategy, assay design, qualification and
transfer to and management of a CRO throughout the IVD and Clinical Biomarker
Lifecycle.

Key
responsibilities are:

  • Develop and qualify assays for patient selection and
    immune-monitoring
  • Perform hands-on cutting-edge bench research to develop IVDs and
    clinical biomarkers to support various cellular therapy platforms.
  • Support assay validation and clinical implementation of the
    selected assays.
  • Assist in transfer, oversight and management of CROs for assay
    validation to ensure timelines are met.
  • Interact with clinical and research teams to address key biological
    questions and drive patient selection strategy.
  • Process and test samples from cancer patients.
    Generate, manage, and analyze data
  • Interact with the Senior Management group.
    Present critical data in a highly organized manner and propose strategies
    for biomarker development for clinical candidate products.
  • Generate development protocols, reports and SOPs
    to support technology development, transfer and regulatory submissions.
  • Participate in the evaluation of advanced
    technologies for IVD and clinical biomarker development.
  • Demonstrate
    accuracy and attention to detail in data analysis and data management.
  • Participate in routine equipment and instrument
    maintenance and perform instrument and/or assay troubleshooting as
    required.
  • The
    ideal candidate for this position is expected to spend a significant
    fraction of his/her time in the laboratory leading and supporting the
    development and qualification of IVD and clinical biomarker assays.

Education and
Experience

  • PhD in a related biological science, with post-doctoral training or
    research experience in the fields of biomarker research, molecular and
    cellular biology is required.
  • PhD with a minimum of 2-5 years' experience working in the
    development of IVD and clinical biomarkers in an industry setting.
  • Experience in IHC, immunoassay and molecular biology techniques is
    required.
  • Deep understanding of cancer biology, cancer immunotherapy, and
    T-cell biology is required
  • Experience in cell-based assay development and qualification is
    desirable.
  • Experience of tech transfer to/from commercial and research
    organizations is desirable.
  • Industry
    experience in Biotech or Pharma is desirable, but we will consider
    candidates with relevant academic experience. Experience working with
    chimeric antigen receptors and adoptive cell therapies is highly
    preferred.
  • Independently motivated and demonstrate the ability to work
    effectively as part of a multi-disciplinary team.

Personal Attributes

§
Quality and detail oriented with high standards

§
Strong planning and organizational skills,
verbal, written

§
Well-developed communication skills, good at
listening and sharing information with others

§
Ability to act on own initiative within
inter-related team communication

§
Must be able to remain in a stationary
position 50%

§
Constantly operates a computer and other
office productivity machinery, such as a calculator, copy machine, and computer
printer

  • Fluent
    verbal and written English language is essential
  • Must
    be able to lift objects of up to 50lbs unassisted


Apply for this position

Click Here to apply