Analytical Development Principal Research Associate

Job Description

Job 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: $ to $ per year

CONTACT:
Send Resume to  Reference . EOE.

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.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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.

#LI-Onsite

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 A