Scientist, Clinical Diagnostics Assay Development

Less than 5 years experience  •  Pharmaceuticals & Biotech

Salary depends on experience
Posted on 06/28/18
La Jolla, CA
Less than 5 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 06/28/18

Role Summary

  • Scientist with primary responsibility of supporting the development of GCLP-compliant clinical cell-based assays suitable for early stage (Phase I and II) clinical studies as a member of the clinical immune monitoring group.
  • Role is focused on flow cytometry assay development and also conduct of cell-based assays on samples acquired as part of early-stage clinical trials.
  • Requires an in-depth technical knowledge of multiparameter  Flow Cytometry using the Becton Dickenson platform, as well as an understanding on relevant software including FACS Diva and FlowJo.
  • Experience of working in a BSL2 level tissue culture laboratory is required, as well as an understanding of cellular immunology and the key assay platforms of ELISPOT and Flow cytometry.
  • Requires a colleague with good analytical skills, attention to detail and a basic understanding of statistics, as well as ability to clearly document and present complex biological data.
  • The role also includes tasks required to operate a compliant laboratory that may include maintenance of equipment, reagent sourcing and/or activities relating to compliance (such as document management).
  • Requires the ability to multitask and work as part of a team that is required to meet business-critical deadlines.

Role Responsibilities

  • Participate in the development of clinical flow cytometry assays in accordance with GCLP requirements.
  • Conduct cell-based immunoassays using clinical samples in accordance with GCLP requirements.
  • Analyze, document and report experimental data in accordance with Pfizer/GCLP requirements.
  • Act as the technical lead for flow cytometry team by maintaining flow cytometers, reagents and associated analytical platforms and software.
  • Maintain specialist knowledge and associated training in order to conduct assays within a BSL2 clinical assay laboratory in a safe and compliant manner.
  • Support the efficient and compliant operation of the laboratory by developing appropriate processes and standard operating procedures, working with others to operate the laboratory, and by becoming an expert user in key areas of operation (such as LIMS and GDMS).
  • Assist in the sourcing and maintenance of reagents and cell banks required to conduct clinical flow cytometry assays in a compliant manner.
  • Maintain and build a broad knowledge of key assay platforms (including flow cytometry and ELISPOT assays) and the scientific rationale underpinning the assays through appropriate training and self-learning.

Basic Qualifications

  • Bachelor degree with at least 6 years of relevant work experience or Master degree with at least 5 years of relevant work experience.
  • Experience in working with human tissue samples.
  • Experience working in a tissue culture laboratory with samples requiring BSL2 containment.
  • Experienced in developing and conducting plate- and Flow- based cellular immune assays.
  • In depth experience of flow cytometry using BD platform.
  • Experience of working in an industrial laboratory with a defined quality system.

Preferred Qualifications

  • Experience of working in a GCLP-compliant environment.
  • Experience in the implementation and use of laboratory information management systems.

Physical/Mental Requirements

  • Primarily based in at the La Jolla site with some travel to collaborating and contracted laboratories.
  • Expected to spend 80% of their time in the laboratory developing and conducting clinical cell based assays and 20% preparing documentation associated with working in a compliant environment.

Organizational Relationships

  • Report to Senior Principal Scientist heading the Clinical Immune Monitoring team.
  • Matrix interaction with program/project teams requiring clinical cell-based assays.
  • Close interaction with the Cancer Vaccine Immunotherapy (CVIT) and Clinical and Diagnostics Assay Development (CDAD) groups.

Resources Managed

  • Support the team running the clinical assay laboratory and managing clinical assays within budget.
  • May supervise the daily activities of more junior staff and contingent staff working in the laboratory.
  • Provide training to other colleagues on standard operating procedures and clinical assays.
  • Potentially train collaborators and contract research organizations to conduct PBMC processing.

Other Job Details:

  • Eligible for Employee Referral Bonus

4698584

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