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 Bachelors 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 Masters 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 Johns 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 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 Vertexs 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 persons 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