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Job Description

Vertex is seeking an experienced analytical development scientist with intensive experience and strong expertise in phase-appropriate method development, validation and transfer for both drug substance and drug products. The successful candidate will partner closely with both internal and external analytical and quality groups to oversee the design, execution, and review of method validation protocols, establish best practices within the organization, and implement a paradigm of continuous improvement that impacts all phases of development. The role ensures robust and efficient completion of all validation activities by working with internal and external partners.

Key Responsibilities:

• Collaborates with project teams to coordinate and oversee the design, execution, and review of analytical method validation activities at both external and internal testing labs.
• Drives continuous improvement initiatives related to phase-appropriate method validation practices within Analytical Development.
• Resolves obstacles associated with resourcing, planning, and execution of method validation activities.
• Ensures the compliance and consistency of method validation practice within the organization.
• Seeks creative approaches to improve accuracy, reliability, flexibility and productivity of method validation activities.
• Assists with training of staff and development of organizational expertise on method validation best practices.
• Perform other duties as assigned.

Education and Experience:

• Ph.D. with 7+ years, Master’s degree with 10+ years, or BS degree with 12+ years of relevant professional analytical development experience
• Extensive experience in the space of method validation and the management of work performed at external testing labs
• 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
• Strong communication skills both oral and written
• Strong knowledge and experience in writing/reviewing analytical reports for regulatory submissions
• Technical expertise on analytical techniques, such as chromatography, KF and spectroscopy
• The ability to work successfully in both a team/matrix environment as well as independently
• Ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects
• Experience with reference standard characterization and management of reference standard materials
• Attention to detail

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