Analytical Development Principal Research Associate

Job Description

JOB TITLE:                         Analytical Development Principal Research Associate           

LOCATION:                       316 Northern Ave., Boston, Massachusetts 02210

OPENINGS:                        1

DUTIES:

• Independently perform complex experimental procedures using various technical platforms, including ELISA, flow cytometry, cell culture, cell-based bioassays, and HPLC, designed through collaboration with supervisor.
• Independently develop ELISA and plate-based binding assays with minimal oversight, in accordance with USP guidelines for biologic assays.
• Improve and transfer a research-grade assay to a GMP test lab.
• Work collaboratively with cross functional teals providing technical support to achieve program goals within established timelines and demonstrating excellent documentation skills.
• Report experimental findings and results to team members in an organized and clear manner.
• Author method documents, analytical protocols, and reports.
• Contribute to lab organization and efficient lab functioning.
• Design development studies with the ability to efficiently assess assay performance.
• Perform statistical analysis of experimental data and interpret results.
• Trend method performance of GMP release and stability assays, identify areas of improvement, and conduct experiments.
• Interact with vendor and contract test labs to transfer and qualify methods following ICH, USP and EP guidelines.
• Design, conduct, and trend stability studies using appropriate statistical tests per ICH and EMA guidelines.
• Present data at cross functional meetings.

REQUIREMENTS:              Employer will accept a Bachelor’s degree, or foreign equivalent in Biology, Analytical Sciences, Biochemistry, Biological Sciences, Pharmacology and Drug Development, or a related field and 5 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation.

Alternatively, employer will accept a Master’s degree, or foreign equivalent, in Biology, Analytical Sciences, Biochemistry, Biological Sciences, Pharmacology and Drug Development, or a related field and 3 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation.

Position requires demonstrable experience in the following:

Hands on experience with cell culture of primary and secondary cell lines, cell line transfections, polymerase chain reaction (PCR), enzyme-linked immunosorbent assay (ELISA), flow cytometry, gel electrophoresis, high performance liquid chromatography (HPLC), statistical programs including John’s Macintosh Project (JMP), and GraphPad Prism. Method development and troubleshooting experience with plate-based binding assays including ELISA, AlphaLISA, and HTFR. Proven technical proficiency and demonstrated skill in designing, executing, and interpreting experiments. Experiments include linearity, accuracy, precision, spike recovery, and forced degradation. Analysis and interpretation of complex experimental data with proficiency in problem solving. Emerging knowledge of regulatory guidance for analytical development. Regulatory guidance includes International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Quality Modules for method development and validation and United States Pharmacopeia (USP) guidance chapters for biologic method development and validation. Knowledge and hands on experience with analytical platforms including JMP and GraphPad Prism used for characterization and release assays.

Rate of Pay:                      $109533.00 - $128500.00

CONTACT:                         Send Resume to [email protected]. Reference 12140.409. EOE.

Pay Range:

Disclosure Statement:

Flex Designation:

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]