job summary: Technical Writer II Job Summary
This role will provide non-testing support to the cGMP QC Analytical department for technology transfer activities. This scope includes coordination of method transfer activity, generating transfer documents to support monoclonal antibody product transfer between the client's 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 tech transfer through collaboration with laboratory subject matter experts (SMEs) and analysts at the client.
location: Andover, Massachusetts
job type: Contract
salary: $27.28 - 32.09 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Authoring method transfer documents using the client's 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
qualifications: Education & Qualifications
- A MS or PhD degree in science, preferably in biochemistry, analytical chemistry or related technical discipline
- Strong technical writing skills including validation and transfer support documents
- Knowledge of the method transfer regulatory guidelines including ICHQ2 and USP<1224>.
- Scientific background in analytical methods, including iCE, CGE, HCP, ProA ELISA and bioassay.
- Working knowledge of QC analytical support and technical writing
- Strong interpersonal, oral and written communication skills.
- A detail-oriented approach to deliverables as the main job responsibility is data review and generation of GMP documentation.
- Past experience supporting GMP writing in the biopharmaceutical field is preferred but not required.
skills: ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.