Process Engineering Scientist I/ II

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

Vertex is seeking a talented individual to join our Process Development group in Boston, MA. Process Development group offers a fast paced and high energy environment. The successful candidate will be responsible for process development and optimization, as well as characterization of cell product for ongoing and future projects.

The candidate will have

* Hands-on experience with hematopoietic stem cells including cell sorting and enrichment, cell culturing, harvest and cryopreservation. * Process optimization including scale-up and scale-down models * Experience applying CRISPR/Cas9 tool and other gene-editing techniques including the use of electroporation * Solid background in understanding principles of molecular and cell biology techniques * Proven track record of applying fundamental scientific and engineering principles to process design, development, and process understanding. * Ability to apply statistical principles to guide process optimization

Key Responsibilities:

* Conduct experiments, characterization and data analyses in support of process characterization and improvement * Develop strategy for process development and optimization * Drive development activities working in a cross-functional environment * Author and review technical reports, regulatory filings, source documents, patents and external publications. * Accountable for troubleshooting and resolving high complex process challenges. * Collaborate within departmental teams, actively contribute to deliverables and engage in team discussion on issue resolution. * Assist in technical transfers to CDMO

Process Engineer Scientist I

Minimum Requirements:

* MS in P harmaceutical Sciences, Chemical Engineering, Bioengineering or related field with at least 3 to 5 years of relevant experience; or BS in P harmaceutical Sciences, Chemical Engineering, Bioengineering or related field and 6+ years of relevant experience; * Hands-on experience working with primary cell culture * Working knowledge of GxP and working under regulatory environment * Experience developing processes for clinical applications * Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities. * Strong organizational skills and high attention to details

OR

Process Engineer Scientist II Minimum Requirements:

* MS in P harmaceutical Sciences, Chemical Engineering, Bioengineering or related field with at least 5 or more years of relevant experience; or BS in P harmaceutical Sciences, Chemical Engineering, Bioengineering or related field and 8+ years of relevant experience; * Hands-on experience working with primary cell culture * Working knowledge of GxP and working under regulatory environment * Experience developing processes for clinical applications * Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities. * Strong organizational skills and high attention to details

Preferred Qualifications:

* Expertise and experience working with primary cell culture ( hematopoietic stem cells) : culturing, sorting, transfection, characterization. Hands on experience with a variety of techniques such as flow cytometers, sorters, and transfection techniques, including electroporation. * Be up to date on recent advances in gene-editing with nucleic acids and CRIPR/Cas9 delivery. * Strong background in applying statistical approaches in the design and analysis of experiments and experience with Quality by Design (QbD) * Experience with early and late stage drug product development and regulatory filings (IND/CTA, NDA/MAA)

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Keywords: Vertex Pharmaceuticals Inc (US), Boston , Process Engineering Scientist I/ II, Engineering , Boston, Massachusetts