What are the responsibilities and job description for the Bioanalysis Research Fellow position at Vertex Pharmaceuticals Incorporated?
Job Description
General Summary:
The DMPK-Bioanalysis department is seeking a highly motivated candidate who is an expert in quantitative bioanalysis of biologics to support our growing portfolio of cell and gene therapies. This individual will have significant hands-on method development experience with multiple ligand binding assay formats, immunogenicity testing, and other quantitative methodologies such as qPCR, Elispot and bDNA . The candidate will utilize their expertise in leading a team to develop and troubleshoot new methods in support of GLP and clinical studies. This individual will establish and implement assay strategies to support novel drug modalities, help create and oversee a CRO network to validate and conduct sample analysis and participate in cross functional teams to realize project goals.
Key Duties and Responsibilities:
- Manage a small team of scientists to provide timely and robust bioanalytical support in advancement of project goals to enable selection of IND candidates and NDA submissions
- Build and oversee CRO network providing assay services in support of cell and gene therapy programs and other non-small molecule modalities
- Serve as a bioanalysis representative in project teams
- A proven track record of accomplishments and leadership across several critical and diverse projects with demonstrated independent problem-solving skills
- Hands-on development experience of robust bioanalytical methods focused on ELISA based quantitation of biologics, including therapeutic proteins and antibodies, and hybridization approaches such as qPCR, Elispot, and bDNA assay for cell and gene therapies
- A complete understanding of global regulatory guidance and expectations for bioanalytical method validation
- Excellent communication skills to deliver key messages clearly and precisely to all levels of the company
- Self-driven dynamic scientist demonstrating ownership thinking
- Monitor assay performance and ensure compliance of regulated assays in support of GLP and clinical studies
- Provide creative and novel bioanalytical solutions to assay challenges and advance the scientific understanding of Vertex's research and development programs
Education and Experience:
- PhD (or equivalent degree) in Analytical Sciences, Biopharmaceutical Sciences, or similar field and 7 years of relevant work experience, or
- Master's Degree (or equivalent) and 10 years of relevant work experience, or
- Bachelor's (or equivalent) and 12 years of relevant work experience
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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.
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 Human Resources at ApplicationAssistance@vrtx.com.