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Process Engineering Senior Scientific Associate
4 months ago
Job Description
At Vertex, our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring cutting-edge transformative therapies to patients as quickly as possible.
The Process Development Engineering Senior Scientific Associate will be responsible for development of Vertex’s cell therapy production platforms and will participate in development of advanced cell processing and culture systems. The role will be part of a team responsible for process development and optimization, as well as characterization of cell product for ongoing and future projects. The position is based in Boston, MA
Key Responsibilities:
Supports the development of upstream production processes for cell therapy projects
Develops protocols and technologies in support of product development from clinical to commercial scale
Applies statistical principals such as DOE/QBD to process development, establish process parameters, and contribute to CMC sections of regulatory filings
Supports technology transfer to CMO and provides manufacturing support for GMP production
Prepares data summaries to support a fully integrated team to facilitate the success of projects
Utilizes understanding of principles of molecular and cell biology techniques when troubleshooting typical problems
Conducts experiments and data analyses in support of process characterization and improvement
Drafts and supports study protocols, technical reports, regulatory filings, source documents, patents, and external publications.
Works within departmental teams, supports deliverables and participates in team discussion on issue resolution.
Other duties:
- Media and materials prep
Required qualifications:
- B.S. in Chemical Engineering , Life Sciences, B.E. in bio-engineering, or related discipline with minimum 3+ years of relevant industrial experience or M.S in Chemical Engineering, Life Sciences or equivalent with 1-2 years of relevant industrial experience
- Process development experience in a bio-pharmaceutical setting working with interdisciplinary and cross functional teams
- Experience working with cell processing devices and bioreactors
- Ability to communicate effectively with a diverse range of scientists and engineers