Analytical Development Principal Research Associate

Posted 2 Days Ago
Be an Early Applicant
Boston, MA
In-Office
88K-132K Annually
Mid level
Biotech • Pharmaceutical
The Role
The role involves developing and analyzing assays for cell-based products, optimizing performance, and writing technical documents. Requires managing analytical reagents and compliance with regulatory standards.
Summary Generated by Built In

Job Description

Employer:                         Vertex Pharmaceuticals Incorporated 

JOB TITLE:                         Analytical Development Principal Research Associate           

LOCATION:                       316 Northern Ave., Boston, MA, 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, 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 an Analytical Development Principal Research Associate-related occupation.

Alternatively, employer will 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-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:                     $88300.00 - $132400.00

CONTACT:                         Send Resume to [email protected]. Reference 12140.579. EOE.

#LI-DNI

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 [email protected]

Top Skills

Alphalisa
Ddpcr
Elisa
Flow Cytometry
Flow-Cam
Rt-Qpcr
Sds-Page
Statistical Analysis
Western Blots
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The Company
HQ: Boston, MA
5,000 Employees
Year Founded: 1989

What We Do

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases.

We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.

Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.

Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.

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