Job DescriptionJob Title: Analytical Development Principal Research Associate
Job Location: 316-318 Northern Ave, Boston, 02210
Openings: 1
Job Type: Full Time
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, Flow-cam, ddPCR, Alphalisa 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:
- Employer will accept a Master's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 2 years of experience in the job offered or in a Analytical Development Principal Research Associate-related occupation.
- Alternatively, employer will accept a Bachelor's degree Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 6 years of experience in the job offered or in a Analytical Development Principal Research Associate-related occupation.
- Position requires demonstrable experience in the following:
- Developing analytical methods in compliance with ICH guidelines. Assisting with the following assay platforms: RT-qPCR, ELISA, Western blots, Flow cytometry or cell- based functional/ potency assays. Assisting with the culture of multiple mammalian cell types and combination drug product (Cells + device) Using literature to design proof of concept studies. Writing technical documents including development reports, qualification protocols and qualification reports.
Rate of Pay: $100,755.00 to $128,500.00 per year
Pay Range:$0 - $0
Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
Flex Designation:On-Site Designated
Flex Eligibility Status:In this
On-Site designated role, you will work
five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
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