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 futuretalent@vrtx.com. Reference 12140.409. 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 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 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 ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortunes 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change peoples lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.