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Sr Scientist/Quality Control

Date Posted: 2/21/2024

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Job Description

We are seeking a Senior Scientist to join a remote team for a project with our client.

The QC Analytical Technology Senior Scientist, Gene Therapy is an established subject matter expert and independently develops and leads projects and investigation study plans to meet CSL Behring deliverables.

Taking project management responsibility for QCAT gene therapy deliverables of moderate to high complexity, the QC Analytical Technology Senior Scientist, Gene Therapy develops and coordinates experimental and documentation activities internally and with CMO partners to meet project and portfolio milestones.

Maintain a safe working environment:

  • Comply with requirements from Safety Program, including Health and Safety mandates, local site-specific regulations and requirements.
  • Responsible for maintaining a safe working environment.
  • Active participation in safety investigations and improvements.

Quality

  • Ensuring actions comply with:
  • Code of Responsible Business Practice
  • Global Quality Policy
  • Site's Quality Manual
  • Current Good Manufacturing Practice as applicable to this role
  • Health, Safety & Environment Management System
  • Stay current with cGMP training as required to maintain compliance with quality and regulatory commitments.
  • Follow documentation and data integrity requirements associated with generation, review and reporting of cGMP activities.
  • Provide independent verification and review and/or approval of data and reports generated to support the development, validation, and analytical lifecycle management of gene therapy methods.
  • Provides expertise in investigation of laboratory and manufacturing deviations, atypical results and method performance issues as a subject matter expert and leads the execution of appropriate testing and interpretation of analytical results.
  • Prepare, review and update standard operating procedures, test procedures, protocols and associated documentation in the performance of development, validation, and analytical lifecycle management studies and investigations.
  • Develop, author and/or review standard operating procedures required to for internal and external cGMP QC activities.

Reliability

  • Responsible for ensuring that all activities performed and led are undertaken in compliance with associated SOPs, procedures, test plans and protocols as appropriate.
  • Manages the development of project plans including estimated cost, time and resources for the identified work activities. Responsible for the oversight and management of moderate to large, complex projects that may be require global project management.
  • Provide technical leadership and project management of moderate to large QCAT projects as required.
  • Responsible for ensuring that the times and costs associated with studies and activities being led and undertaken are accurately recorded and reported for both financial and resource management.
  • Reports on the status and costs associated with the projects and studies being led to Head of QCAT and project sponsors.
  • Manages projects, investigations, regulatory submissions and during audits and inspections as a technical and subject matter expert.
  • Responsible for the management of the analytical lifecycle of methods within the area of technical and subject matter expertise.
  • Responsible for ensuring appropriate maintenance and calibration of laboratory equipment is maintained.

Innovation

  • Scouting and evaluation of new technologies within the field of expertise.
  • Lead the remediation of analytical challenges through method improvements, as well as development and implementation of new methods and innovative technologies.
  • Independentl
    To apply please email your resume to mdelaney@rothstaffing.com

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Job Snapshot

  • Employee Type:Contractor
  • Location:King Of Prussia, PA
  • Job Type:Biotech
  • Experience:3-5 years
  • Education:4 Year Degree
  • Date Posted:2/21/2024
  • Contact: Melanie Delaney (949) 271-2973
  • Pay Range: $0.00 - $67.00 Hourly
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Job Reference: JN -022024-359519