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WHAT
IN
Scientist II Analytical Development
Job
Vertex Pharmaceuticals
US
-
Cambridge,
Massachusetts
Job Code - 673BR
Position - FULL TIME
Job First Active on: Sunday, November 01, 2009
APPLY TO THIS JOB (You will be applying directly to Vertex Pharmaceuticals for this position!)
JOB DESCRIPTION: Scientist II, Analytical Development
Vertex is seeking a talented individual to join our Analytical Development group in Cambridge, MA. Consistently and passionately challenging the boundaries of their knowledge, our Analytical Development team employs traditional and innovative analytical techniques and Quality-by-Design principles to develop and validate the analytical tools used to ensure the safety, efficacy and quality of Vertex pharmaceutical products. As a Scientist II / Senior Scientist in the Analytical Development group, 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:
- Set drug substance and drug product specifications with the understanding of clinical study design and CMC processes
- 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
REQUIREMENTS - QUALIFICATIONS: Scientist II, Analytical Development
- A Ph.D., Master's, or Bachelor's degree in the life sciences or physical sciences with a preference for a concentration in Chemistry, Analytical Chemistry or Pharmaceutical Chemistry
- 3+ years (PhD), 5+ years (MS) or 8+ years (BS) current, relative industry experience working in drug substance and drug product support
- A broad understanding of the drug development process, including clinical design, chemical development, and formulation development, especially how these processes impact analytical method development, validation, and method transfer
- Working knowledge of the risks that exist in all aspects of method development, validation and transfer and the ability to use risk analysis and quality-by-design (QbD) approaches to develop robust methods, design appropriate validation protocols to validate methods for their intended use, and ensure successful method transfer are essential
- Experience working with in ICH and FDA method validation guidelines with preference for the ability to identify areas overlooked by these guidelines
- Hands-on GMP experience with a preference for a background in developing GMP friendly methods
- Skilled in HPLC, LC-MS, GC, GC-MS, FT-IR, UV-VIS, KF, NMR, dissolution and other instruments
- The ability to work successfully in team/matrix environment as well as independently
- The ability to work in a fast pace environment, to manage priorities, and to maintain timelines for multiple projects
- Excellent written and verbal communication skills
Although Vertex does not have an active opening, we are interested in establishing relationships with well qualified and talented individuals for future opportunities in our Analytical Development group in Cambridge, MA.
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, inflammation, autoimmune diseases, cancer, pain and bacterial infection.
Vertex Pharmaceuticals
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