Research Investigator/Scientist, Analytical Development - Cell Therapies
Job ID R0021458 Date posted 07/21/2020 Location Boston, Massachusetts
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As a RI/Scientist, Analytical Development, Cell Therapy working on the Pharm Science, you will be empowered to build a world class cell therapy team.
This RI/Scientist position will play an important role in late stage analytical development and transfer for cellular therapy products and driving the project towards clinical. With some supervision, the individual plans and executes assay development and validation; prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials; presents study results at team or department meetings, to external partners or at conferences.
- Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
- Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks.
- Contributes significantly to project work which may include multiple projects within functional area.
- Reviews, interprets and communicates data cross-functionally within CMC and/or project teams.
- Plans and implements resolutions to technical problems/issues
- Represents functional area on GCT project teams by communicating activities from designated functional area to project team
- Supports local and global initiatives which may include leading initiatives or work streams
- Serves as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/trainer.
- Designs and executes experiments, and reports results
- Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
- Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
- Proactively analyses manufacturing issues and coordinates potential resolution with the CMC team.
- Responsible for integrating scientific/technical efforts around cross-functional issues
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- PhD in chemistry, biology, pharmacy, chemical or biomedical engineering or related pharmaceutical science
- In-depth knowledge and experiences in molecular, cell based immune assays and cell banking
- Excellent written, communication and presentation skills
- Understanding of viral vector and cell analytics
- Experience of analytical assays qualification and tech transfer
- Experiences in cellular characterization and functional assays, e.g. flow cytometry, qPCR, ddPCR, cytokine/chemokine production and cytotoxicity assays
- Understanding of cell therapies and/or GMP operation is a big plus
- May require approximately 5-10% travel.
Boston, MAWorker Type
Job ID R0021458
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