Associate Director, Bioanalytical Assay Development
Vertex Pharmaceuticals is seeking an experienced Scientist who brings enthusiasm, intellectual curiosity, scientific rigor and a desire to innovate new medicines for patients.
- Assume responsibility for developing and validating bioanalytical methods to support preclinical and clinical development of novel gene editing therapeutic candidates.
- Assays to be developed include (but are not limited to) antibody assays, ELISpot, qPCR, RT-PCR and biomarker quantitation.
- Work closely with research to transfer and optimize assays for further development.
- Identify and manage Contract Research Organizations (CROs) to support assay development, validation and sample analysis.
- Hire and assume responsibility for a small group of Scientists and Research Associates supporting Gene Therapy Bioanalytical Assay Development.
- Ensure all activities are conducted in compliance with the appropriate regulations and are aligned with regulatory agency expectations.
- Author, review and finalize validation reports, IND sections and responses to regulatory agency questions regarding bioanalytical methods and sample analysis.
- Effectively collaborate with a fully integrated team to facilitate the success of projects.
- Additional duties and responsibilities as required.
- PhD or equivalent in a relevant biological discipline and at least 6 years of relevant pharmaceutical industry experience.
- Deep knowledge of bioanalytical assay development, qualification and validation requirements to comply with current regulatory standards, particularly biotherapeutics immunogenicity and molecular assay development.
- Proficient in relevant analytical methodology, emerging new technologies, troubleshooting and problem solving.
- Experience in CRO management and oversight for bioanalytical assay development, validation and sample analysis.
- Working knowledge of Good Laboratory Practices (GLP).
- Familiarity with AAV vectors and/or CRISPR/Cas9 system.
- Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team.
- Demonstrated capacity to work in a fast-paced environment with strong attention to detail.
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 2,500 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. For additional information and the latest updates from the Company, please visit www.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 Talent Acquisition at ApplicationAssistance@vrtx.com.