Analytical Development Principal Research Associate

Posted Yesterday
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Boston, MA, USA
In-Office
101K-129K Annually
Senior level
Biotech • Pharmaceutical
The Role
Design, develop, execute and analyze analytical and release assays for cell-based products using multiple platforms (RT-qPCR, ELISA, flow cytometry, ddPCR, AlphaLISA). Troubleshoot and optimize assays, perform DOE and statistical validation, manage reagents and reference standards, author protocols/reports, transfer assays to QC, and maintain detailed documentation to support assay qualification and validation.
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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:                     $100,755.00 to $128,500.00 per year

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

Skills Required

  • Master's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or related field plus 2 years relevant experience
  • Bachelor's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or related field plus 6 years relevant experience
  • Developing analytical methods in compliance with ICH guidelines
  • Hands-on experience with RT-qPCR, ddPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry, Flow-cam, AlphaLISA, and cell-based functional/potency assays
  • Experience culturing multiple mammalian cell types and working with combination drug products (cells + device)
  • Use of Design of Experiments (DOE) and contemporary development tools for assay design
  • Perform statistical analysis to establish specificity, sensitivity, linear range, precision, and accuracy of methods
  • Establish reference standard materials and support assay validation and qualification
  • Transfer assays to QC and provide SME support; author transfer/qualification protocols and reports
  • Strong technical writing and documentation skills (development reports, qualification protocols/reports, lab notebooks, test forms)

Vertex Pharmaceuticals Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.

  • Parental & Family Support Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
  • Leave & Time Off Breadth Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
  • Retirement Support Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.

Vertex Pharmaceuticals Insights

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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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