Job DescriptionThis role provides testing support for Release and Stability Laboratory (RSL) department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible to ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.KEY RESPONSIBILITIES:* Perform in-process, release, and stability testing independently following established methodology, procedures and SOPs* Participate in executing method validations and/or method transfers* Troubleshoot analytical methods with the assistance of supervisor when necessary* Maintain accurate testing records and adhere to cGMP/GDP expectation* May be required to author and review data, SOPs, analytical methods, protocols and reports* Participates in compliance related teams working towards the goal of continuous improvement.EDUCATION AND EXPERIENCE:* A minimum of a Bachelor Degree in science or related discipline is required.* 6+ years of experience in GMP pharmaceutical/biopharmaceutical industry with at least 2 years of method validation/transfer experience.* Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections.* Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements. Expertise with HPLC and/or GC is required.* The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential.* Strong attention to detail* Effective communication skills, both verbal and written.Company InformationVertex 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.
Location/Region: Boston, MA (02298)