Analytical Chemist, Scientist II
Vertex is seeking a talented individual to join our Analytical Development group in Cambridge, MA.
As a member of the Analytical Development team, this role will support the drug development programs at Vertex through analytical method development, validation and transfer efforts, with special emphasis on drug substance support, drug product support or both. With an expertise in laboratory techniques commonly used in the analysis of pharmaceutical products, this position will help to ensure that suitable methods are in place at Vertex.
Key Responsibilities include but are not limited to:
- Set drug substance and drug product specifications with the understanding of clinical study design and CMC process
- Justify and set retest period, storage, and shipping conditions
- Understand drug substance and drug product in the context of chemical development and formulation development to identify and document critical factors that effect method performance
- Identify critical in-process-control issues and develop appropriate IPC methods
- Design stability studies for drug substance and drug product
- Conduct risk analysis in all aspects of method development to efficiently develop robust methods that are GMP friendly based on quality by design
- Design validation protocols that are in compliance with ICH and FDA guidelines; further more, identify critical factors that may not be mandated by the guidelines but are essential for validating the methods for their intended use
- Serve as the direct contact with contract manufacturing and testing labs to ensure optimal method performance during method transfer.
- Timely monitor and evaluate release and stability data from CMO and CRO for GMP compliance, potential out of specification, out of trend, and method performance issues to conduct investigations and implement corrective actions as needed.
- Present to cross functional teams and effectively communicate critical analytical issues and solutions
- Develop, review, and approve source documents for regulatory submissions
- A Ph.D. or Master's or Bachelor's degree in the life or physical sciences with a preference for a concentration in Chemistry, Analytical Chemistry or Pharmaceutical Chemistry
- 0 - 3 years (PhD), 3 - 5 years (MS) or 6+ years (BS) current relative industry experience working in drug substance and drug product support
- Scientist II: 3 - 5 years (PhD), 5+ years (MS) or 8+ years (BS) current relative industry experience working in drug substance and drug product support
- Broad understanding of the drug development process, including clinical design, chemical development, and formulation development, especially how those processes impact analytical method development, validation, and method transfer are essential
- High level understanding of risks in all aspects of method development, validation and transfer and the ability to use risk analysis and quality- by-design approaches to develop robust methods, design appropriate validation protocols to validate methods for their intended use, and ensure successful method transfer are essential
- Good understanding of ICH and FDA method validation guidelines are essential. The ability of identifying areas overlooked in the guidelines is preferred.
- Good understanding of GMP and hands-on GMP experience as well as how to develop methods that are GMP friendly are preferred.
- Skilled in HPLC, LC-MS, GC, GC-MS, FT-IR, UV-VIS, KF, NMR, dissolution and other instruments
- The ability to work successfully in both a team/matrix environment as well as independently
- The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects
- Excellent written and verbal communication skills
- Established organizational skills
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain.