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.
- 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
- 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
- Good Manufacturing Practices
- High Performance Liquid Chromatography
- Lifecycle Management
- Method Validation
- Quality Control