Senior Scientist Analytical Development
Vertex is seeking a talented individual to join our Analytical Development group in Boston, MA. As an experienced member of the Analytical Development team, this role will supervise and organize a variety of scientific functions encompassing small molecule Drug Substance and Drug Product late stage development, and will provide day to day leadership for specific projects assigned. Experience with writing regulatory submissions is expected. Knowledge of cGMPs and Regulatory guidelines is required. Mentorship of junior technical staff is expected, with particular focus on HPLC and GC. Direct supervisory experience is desired. The ability to work both independently and in a matrix team environment is essential.
Key Responsibilities include but are not limited to:
- Oversees and coordinates aspects of product and analytical method development
- Defines, develops and conducts experiments that are in compliance with applicable regulations and SOPs
- Interfaces with CROs to transfer methods and is a point of contact for investigations and other product development activities
- Performs overall review of data generated on development and clinical supply samples
- Develops, reviews and approves source documents for regulatory submissions
- Authors, reviews, and approves SOPs, analytical methods, protocols, and reports
- Mentors and supervises staff and is responsible for the quality and accuracy of the work done by others.
- Presents to cross functional teams and effectively communicates critical issues and solutions to staff at all levels within the organization.
- Technical expert for data review and interpretation
- Ph.D. in Analytical Chemistry, or related field
- Minimum Experience: 5+ years experience within the Pharmaceutical Industry.
- Strong skills in Analytical chemistry are required.
- An in-depth knowledge of HPLC and GC, including both theory and practice is required.
- The ability to work successfully in both a team/matrix environment as well as independently is essential.
- The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is essential.
- Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals are required.
- Knowledge of cGMPs, Regulatory guidelines and additional analytical techniques (MS, KF, dissolution) are desirable.
- Limited travel is required. An ability to travel 10% is a requirement.
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, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. 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.