As a Scientist, Analytical Development, Cell Therapy working on the Pharm Science, Cell Therapy team, you will be empowered to build a world class cell therapy team and a typical day will include:
This scientist position will play an important role in developing analytical methods for developing cellular therapy products. Independently plans and executes assay development, characterization and qualification studies. 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 and independently 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.
- Independently 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, AND SKILLS:
- PhD in chemistry, biology, pharmacy, chemical or biomedical engineering or related pharmaceutical science; 0-2 years relevant industry experience
- In-depth knowledge and experiences in T cell, NK cell immunology or stem cell biology (e.g. iPSC culture and differentiation) is strongly preferred.
- Expertise on xenograft animal models to assess Cell therapy product functions.
- Experiences in developing and executing cellular characterization assays and demonstrated expertise in one of the following areas - flow cytometry, multiplexing soluble protein platforms, RNAseq and/or single cell characterization platforms.
- Understanding of viral transduction process and viral analytics is strongly preferred
- Understanding and experience of analytical assay validation is a plus.
- Previous exposure to GMP manufacturing of cell therapy or biological products, or participation in technical transfer of clinical processes to a CMO, or tech transfer of product release & characterization or clinical assays to a CRO, or other third party is a plus
- May require approximately 5-10% travel