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Job Description

General Summary:

Vertex Pharmaceuticals is excited to introduce a new opportunity for a Sr. Principal Scientist in Analytical Development. The ideal candidate will be a collaborative professional with extensive experience and expertise in phase-appropriate method development, validation, and transfer for small molecule drug substance and drug products. In this role, you will work closely with internal and external analytical and quality groups, taking a lead role in overseeing the design, execution, and review of method validation protocols and reports. As a Sr. Principal Scientist, you will be instrumental in establishing best practices within the organization and driving a paradigm of continuous improvement that positively impacts all phases of development.

Key Responsibilities:

• Collaborate with project teams to coordinate and oversee the design, execution, and review of analytical method validation activities at both external and internal testing labs.
• Drive continuous improvement initiatives related to phase-appropriate method validation practices within Analytical Development.
• Resolve obstacles associated with resourcing, planning, and execution of method validation activities.
• Ensure the compliance and consistency of method validation practice within the organization.
• Seek creative approaches to improve accuracy, reliability, flexibility, and productivity of method validation activities.
• Assist with training of staff and development of organizational expertise on method validation best practices.

Knowledge and Skills:

• Technical expertise for troubleshooting, data review, and interpretation.
• In-depth knowledge of pharmaceutical industry regulations and guidelines.
• Expertise on GMP concepts and practices.
• Strong organizational and project management skills.
• Proven leadership skills and the ability to collaborate effectively across teams.
• Knowledge of best practices in analytical development and a commitment to continuous improvement.
• Excellent communication skills which include presenting scientific concepts.
• Strong knowledge and experience in writing/reviewing analytical reports for regulatory submissions.
• Expertise in analytical techniques, such as chromatography, KF, dissolution, and spectroscopy.

Education and Experience:

• Ph.D. with 7+ years, Master's degree with 10+ years, or BS degree with 12+ years of relevant experience within the pharmaceutical industry with a focus on small molecules.
• Extensive experience in the space of method validation including the management of work performed at external testing labs.

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