Process Development Engineering Senior Scientist - Cell Cryopreservation

Job Description

General Summary:

Vertex is seeking a talented individual to join our CMC Process Development team as an industry experienced Senior Scientist. The primary focus of this role is to lead the design and execution of cryopreservation development studies for a cell-based drug candidate for the treatment of diabetes. This Senior Scientist will provide the technical expertise to drive cryopreservation process development and optimization including formulation, freezing/thawing procedures, and scale-up.

The CMC Process Development group offers a fast-paced and high energy environment. The right candidate will be a subject matter expert cell therapy cryopreservation and have a solid technical operations background.

Key Responsibilities:

• Design and execute experimental studies to support cryopreservation development and optimization to deliver a process which achieves target safety, stability, and product quality
• Work with external collaborators to evaluate novel and emerging technologies
• Design and interpret experimental studies, maintain laboratory notebooks, and present at cross-functional meetings
• Drive development activities working in a cross-functional environment
• Represent the CMC development team as a cryopreservation subject matter expert
• Accountable for troubleshooting issues involving a high degree of complexity
• Collaborate within departmental teams, actively contribute to deliverables and engage in team discussion on issue resolution
• Generate hypotheses to pursue project goals and set new experimental directions
• Apply DoE/QbD principals to process characterization, establish process parameters, and contribute to CMC sections of regulatory filings
• Author, review, and refine technical reports to provide definitive interpretations and recommendations
• Responsible for all aspects of the project(s) within their area of expertise
• Identify and manage external development work, as appropriate

Minimum Requirements:

• PhD. in chemical or biomedical engineering, pharmaceutical sciences, biochemistry, or related discipline with 2+ years of industry experience or (MS) with 6+ years of industry experience or (BS) with 8+ years of industry experience
• Relevant experience and technical expertise in cell cryopreservation development
• Ability to design and apply statistical principles to guide process optimization
• Demonstrates intellectual and technological leadership
• Demonstrates ability to research and utilize trending science to drive innovation and find new, creative paths to solve difficult and important problems
• Prior experience with cell therapy process development
• Working knowledge of GxP
• Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities
• Strong organizational skills, high attention to details, and ability to work in a collaborative environment

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Flex Designation:

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com