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Analytical Scientist / Method Transfer (Pharma Industry) / REMOTE-WORK job in Atlanta at Pioneer Data Systems Inc

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Analytical Scientist / Method Transfer (Pharma Industry) / REMOTE-WORK at Pioneer Data Systems Inc

Analytical Scientist / Method Transfer (Pharma Industry) / REMOTE-WORK

Pioneer Data Systems Inc Work from Home/Remote Full-Time
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Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Analytical Scientist / Method Transfer / REMOTE-WORK to join their expanding team.

Position Details:
  • Job Title: Analytical Scientist / Method Transfer (Pharma Industry) / REMOTE-WORK
  • Duration: 18 months contract, extendable up to 36 months
  • Location: Remote Work (Work From Home)
  • Client Location: Andover, MA

  • The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
  • You may participate in the company group medical insurance plan

Job Description:
  • True job title: Quality Control (QC) Tech Transfer Contractor
  • Not an IT position
  • This role will provide non-testing support to the QC Analytical department for product life cycle management and technology transfer activities.
  • This scope includes coordination of generating validation and transfer documents to support monoclonal antibody product life cycle and transfer between Pharmaceutical sites.
  • The technical skills within scope will require understanding of the scientific principles of test methods, data analysis and cGMP requirement.
  • The candidate will be responsible for facilitating lifecycle management and tech transfer through collaboration with laboratory subject matter experts (SMEs) and analysts at Pharmaceutical.

  • Authoring method validation and transfer documents using Pharmaceutical document workflow, through collaboration with SMEs
  • Supporting lab testing by reviewing data and documents for accuracy and compliance.
  • Supporting assay improvement activities and generating supporting documents.
  • Participating in across site meeting and tracking the project timeline
  • Supporting critical reagent, reference material and change control activities
  • Communicating with receiving laboratory, SME and supporting gap assessment, sample request and queries for technical transfer

Successful candidate requires:
  • Knowledge of the method validation and transfer regulatory guidelines
  • Scientific background in analytical methods, including HPLC, iCE, CGE, ELISA and bioassay.
  • Knowledge of QC analytical support and technical writing
  • Strong interpersonal and written communication skills
  • A detail-oriented approach to deliverables as the main job responsibility is data review and generation of GMP documentation
  • A degree in science, preferably in biochemistry, analytical chemistry or related technical discipline
  • Past experience supporting GMP writing in the biopharmaceutical field is preferred but not required
  • Can be 100% remote

Recommended Skills

  • Good Manufacturing Practices
  • High Performance Liquid Chromatography
  • Lifecycle Management
  • Method Validation
  • Pharmaceuticals
  • Quality Control
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