Vertex is seeking a talented individual to join our Analytical Development group in Boston, MA. This role will support the drug development programs at Vertex as a Subject Matter Expert (SME) expert in chiral chromatography, and as a leader within the chromatography SME team. The chromatography SME team is responsible for the development of all HPLC methods required for Drug Substance, Drug Product Intermediate, and Drug Product across all Vertex clinical programs, utilizing statistical design of experiment approaches (DoE) and in-silico tools to identify the most robust operating space. Expertise in HPLC and good understanding of chiral column selection and screening approaches (e.g. normal phase, reverse phase, supercritical fluid) as applied to small molecule pharmaceutical products is required. Hands-on experimental work is expected, as is the ability to work both independently and in a matrix team environment. As an experienced member of the chromatography SME team, this role will be responsible for the strategy, planning, execution, and alignment required to advance methods for assigned projects, and those of direct reports. Knowledge of cGMPs and Regulatory guidelines is required, particularly related to method validation. Mentorship of junior technical staff is expected, with emphasis on chiral chromatography. Opportunity to develop departmental strategy and approach related to method development and chiral separations.
* Defines, develops, and conducts experiments that follow applicable regulations and SOPs. Maintains accurate records of experiments and results in a laboratory notebook and authors reports as assigned.
* Interfaces with project teams to define analytical method target profiles, and designs and conducts experiments to develop phase appropriate methods and validation strategy to support clinical drug substance and drug product release and stability.
* Designs, executes, and interprets experiments with a high degree of reliability, independence, and attention to detail. Utilizes software tools (Fusion QbD, DryLab, etc.) to model experimental design space in order to identify a robust operating region. Acts as a resource for investigations and events related to method performance.
* Develops, reviews and approves source documents for regulatory submissions
* 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 colleagues at all levels within the organization. Technical expert for separations of chiral species (particularly small molecules with multiple chiral centers)
* A Ph. D. or Master's in Analytical Chemistry.
* 6-10 years (PhD) or 9-13 years (MS) experience within the Pharmaceutical Industry.
* Strong skills in Analytical chemistry and chromatography, particularly significant experience with chiral screening and chiral method development related to the analysis of chiral molecules, is required. Experience developing methods for entities with multiple chiral centers is preferred.
* The ability to work successfully in both a team/matrix environment as well as independently is essential.
* The ability to work in a fast paced environment, manage priorities, and maintain timelines for multiple projects is essential.
* Experience managing small teams of laboratory scientists (2-4 direct reports) is preferred.
* Knowledge of cGMPs and Regulatory guidelines pertaining to compliance, documentation, and method validation is required.
* Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals are required.