Specialist-Technical Support Release and Stability Lab
This role provides technical 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.
- Assist in overseeing of RSL method validations and/or method transfer activities to support project timelines.
- Serve as RSL representative in cross-functional, cross-departmental working teams
- May execute method validations and/or transfers as needed
- Support in the managing of RSL change controls, deviations, and investigations.
- Authors laboratory OOS/OOT investigations and deviations. Helps identify corrective actions to prevent reoccurrence
- Assist in troubleshooting of analytical methods when necessary
- Authors and reviews data, SOPs, analytical methods, protocols and reports
- Participates in compliance related teams working towards the goal of continuous improvement.
- A minimum of a Bachelor Degree in science or related discipline is required.
- 4+ years of experience in pharmaceutical/biopharmaceutical industry with at least 1 year of method validation/transfer experience.
- Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections.
- Knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements
- Strong attention to detail
- Effective communication skills, both verbal and written.
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.