Senior Scientist Analytical Development

Vertex - Boston, MA (30+ days ago)3.6


Job Description:
Vertex is seeking a talented individual to join our Analytical Development group in Boston, MA. As a member of the Analytical Development team, this role will support small molecule drug development programs at Vertex. Specifically, the individual will lead analytical chemistry efforts on designated projects in alignment with other CM&C functions, Regulatory, Toxicology, and Quality Assurance. The role will include management of a small group, in addition to providing independent contributions as dictated by project needs. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are criteria for success.

Key Responsibilities include but are not limited to:
Set and justify 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 chemical development, solid state development, and formulation development to identify and document critical factors that impact method performance and/or analytical development activities
Develop, validate and transfer (as applicable) analytical methods, suitable for progressive stages of pharmaceutical development and/or supervise activities
Identify critical in-process-control issues and develop appropriate IPC methods
Design stability studies for drug substance and drug product
Serve as the direct contact with contract manufacturing and testing labs
Timely monitor and evaluate release and stability data from CMOs and CROs for GMP compliance, potential out of specification, out of trend, and method performance issues and supervise or 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
Design validation protocols that are in compliance with ICH and FDA guidelines, and identify critical factors that may not be mandated by the guidelines but are essential for validating the methods for their intended use
Manage all activities of a small group
Motivate personnel and resolve conflicts; responsible for feedback, performance reviews, hiring and development of staff
Perform other duties as assigned
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Qualification:
A Ph.D. with 7+ years of relevant analytical development experience, Including 2+ years of supervisory experience
Broad understanding of the drug development process, including clinical design, toxicology, regulatory filings, chemical development, solid state development, and formulation development, and the interrelationship with analytical development is essential
Demonstrated leadership skills and excellent verbal and written communication skills are essential
Good understanding of ICH, FDA, and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
Excellent interpersonal and team skills are required
Skilled in HPLC, LC-MS, GC, GC-MS, FT-IR, UV-VIS, KF, NMR, dissolution, and broad knowledge of other techniques used in pharmaceutical analysis
The ability to work successfully in both a team/matrix environment as well as independently is required
The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple activities are required