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Job Description

JOB TITLE: Analytical Development Principal Research Associate, Cell Analytical Development

LOCATION: 316 Northern Ave, Boston, Massachusetts 02210

OPENINGS: 1

DUTIES:

• Design, develop, execute and analyze characterization and release assays for identity, purity, strength and potency of cell- based products. Multiple analytical platforms will be employed including RT-qPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry and cell- based functional/ potency assays.

• Execute test methods in support of pluripotent stem cell Process Development activities.

• Troubleshoot, optimize, and trend assay performance.

• Report on project progress, write analytical development protocols and reports, provide recommendations to management.

• Identify, qualify, and manage analytical reagents as per regulatory standards.

• Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools.

• Perform statistical analysis to establish specificity, sensitivity, linear range, precision, and accuracy of test methods.

• Establish reference standard materials as required to support assay validation.

• Transfer assays to QC and provide SME support for assay qualification, author transfer/qualification protocols and reports.

• Maintain excellent written documentation (e.g. lab notebook and test forms).

REQUIREMENTS: The position requires a Master’s degree (or foreign equivalent) in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 2 years of experience in the job offered or in an Analytical Development Principal Research Associate, Cell Analytical Development-related occupation.

Alternatively, employer will also accept a Bachelor’s degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 6 years of experience in the job offered or in an Analytical Development Principal Research Associate, Cell Analytical Development-related occupation.

Position requires demonstrable experience in the following:

• Developing analytical methods in compliance with ICH guidelines.

• Experience with the following assay platforms: RT-qPCR, ELISA, Western blots, Flow cytometry or cell- based functional/ potency assays.

• Experience with the culture of multiple mammalian cell types.

• Using literature to design proof of concept studies. Writing technical documents including development reports, qualification protocols and qualification reports.

CONTACT: Send Resume to Sarah Hadjian at sarah_hadjian@vrtx.com. Reference 12140.434. EOE.

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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