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Job Description

The Translational Engineering Principal Scientific Associate will have a lead role in the technical operations of cell culture and encapsulation processes supporting the T1D research engineering team in Providence, RI. The ideal candidate has an extensive background performing aseptic technical operations with knowledge of stem cell culture and macro/micro encapsulation technologies. A strong candidate will have experience in technical operations and execution with supervisory responsibilities. Experience in aseptic filling operations in a GMP environment desired.

This role may require periodic weekend work.

Key Responsibilities:

• Ensures operational readiness of all equipment required for aseptic filling processes for in-vitro and preclinical studies.
• Guides and supervises the daily technical operations and activities of junior associates on cell process and encapsulation team.
• Interfaces with engineering research SMEs facilitating on-going research and development for cell encapsulation, drug substance, and drug product development.
• Maintains state of research aseptic cell processing and filling suite through collaboration with relevant cross functional groups (facilities and EHS).
• Provides technical support of scaled unit operations for 3L bioreactor culture and device filling (includes inventory and autoclaving of all materials required for aseptic filling, media preparation, and collation of quality samples required for study assessment).

• Executes routine cell culture activities and maintenance, including reagent preparation and media formulation for small scale cell culture up to 3L bioreactor culture.
• Routinely performs and supports study leads with analytical bioassays evaluating function of islet cell cultures, in-device constructs, and other next-generation encapsulated drug products.
• Executes ELISAs and other cell-based assays for scientist review and collaboration with cross-functional project leads.
• Develops knowledge of the relevant device filling processes and supports aseptic filling and stability testing initiatives.
• Works cross-functionally with engineering sciences to support combination modalities; demonstrates proven written and verbal ability to present or discuss those relationships on critical studies.
• Maintains compliance with all on-going training requirements required for GxP.
• Follow SOPs, policies, and all other relevant work instructions to ensure successful and compliant operations.

• Use analytical methods to carry out sample analyses, including but not limited to cell and tissue characterization assays: operating a balance, cell counting and viability assessments, microscopy and metabolic assays.
• Maintains ELN (electronic lab notebook) records and analyzes data to sustain GxP compliance.

Knowledge and Skills:

• Experience with aseptic cell culture and sample processing experience is required.
• Experience with sterilization and preparation of lab equipment needed.
• Experience with daily lab operations including safety, cleaning, maintenance, ordering, tracking supplies, and documentation.
• GMP experience preferred.
• Demonstrated ability to learn new systems and understand new technologies.

• Analytical skills to calculate reagent concentrations and dilutions.

• Excellent organizational skills and demonstrated experience in good documentation practices.
• Ability to work independently and manage priorities with management directives.

• Strong attention to detail, proactive, with track record of implementing continuous improvement.
• Effective communication skills, both verbal and written.

Required Education and Experience:

• BS in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, and or biology related degree with 5+ years of experience or MS with 2+ years of experience
• Hands-on experience working with cell culture, routine cell-based assays, flow cytometry, and ELISAs (ideally in a GMP environment)
• Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities
• An operational mindset with strong organizational skills and high attention to detail

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