Technical Writer III at Integrated Resources, Inc
Andover, MA 01810
About the Job
REMOTE
position will start remote and then could require onsite support depending on COVID restrictions
Exact Job Title: Techincal Writer
Duration: 18 month
Job Description for Quality Control (QC) Tech Transfer Contractor Position Reports to: Hong Liu, Quality Control This role will provide non-testing support to the QC Analytical department for technology transfer activities. This Product includes coordination of method transfer activity, generating transfer documents to support monoclonal antibody product transfer between Client sites. The technical skills within Product will require understanding of the scientific principles of test methods, data analysis and cGMP requirement. The candidate will be responsible for facilitating tech transfer through collaboration with laboratory subject matter experts (SMEs) and analysts at Client. The key responsibilities of the candidate are as follows:
Authoring method transfer documents using Client document workflow, through collaboration with SMEs Supporting lab testing by reviewing data and documents for accuracy and compliance.
Supporting assay remediation activities and generating supporting documents.
Participating in across site tech transfer meeting and tracking the project timeline Supporting sample/resource request and coordinating sample shipment and documentation Communicating with receiving laboratory and supporting gap assessment, sample request and queries Successful candidate requires:
Knowledge of the method transfer regulatory guidelines including ICHQ2 and USP<1224>.
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 BS with over 5-year experience, MS over 3-year experience or PhD degree in biochemistry and analytical chemistry Past experience supporting GMP writing in the biopharmaceutical field is preferred but not required.
position will start remote and then could require onsite support depending on COVID restrictions
Exact Job Title: Techincal Writer
Duration: 18 month
Job Description for Quality Control (QC) Tech Transfer Contractor Position Reports to: Hong Liu, Quality Control This role will provide non-testing support to the QC Analytical department for technology transfer activities. This Product includes coordination of method transfer activity, generating transfer documents to support monoclonal antibody product transfer between Client sites. The technical skills within Product will require understanding of the scientific principles of test methods, data analysis and cGMP requirement. The candidate will be responsible for facilitating tech transfer through collaboration with laboratory subject matter experts (SMEs) and analysts at Client. The key responsibilities of the candidate are as follows:
Authoring method transfer documents using Client document workflow, through collaboration with SMEs Supporting lab testing by reviewing data and documents for accuracy and compliance.
Supporting assay remediation activities and generating supporting documents.
Participating in across site tech transfer meeting and tracking the project timeline Supporting sample/resource request and coordinating sample shipment and documentation Communicating with receiving laboratory and supporting gap assessment, sample request and queries Successful candidate requires:
Knowledge of the method transfer regulatory guidelines including ICHQ2 and USP<1224>.
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 BS with over 5-year experience, MS over 3-year experience or PhD degree in biochemistry and analytical chemistry Past experience supporting GMP writing in the biopharmaceutical field is preferred but not required.
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| What is the minimum education experience required?: | A BS with over 5-year experience, MS over 3-year experience or PhD degree in biochemistry and analytical chemistry |