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Senior Scientist Analytical Development
at Vertex
Boston, MA

Senior Scientist Analytical Development
at Vertex
Boston, MA

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Description

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, you will support small molecule drug development programs at Vertex. Specifically, you will lead analytical chemistry efforts on designated projects in alignment with other CM&C functions, Regulatory, Toxicology, and Quality Assurance. Additionally, you will serve as a subject matter expert for Parenteral Formulations. You will manage a small group, as well as provide independent contributions based on project needs. To be successful you will need the ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams.

Key Responsibilities:

  • Establish Analytical Strategy for parenteral formulations to ensure compliance for projects in preclinical through NDA
  • Provide mentorship across teams on requirements for parenteral formulations
  • Set and justify drug substance and drug product specifications
  • Justify and set retest period, storage, and shipping conditions
  • Understand chemical development, solid state development and formulation development.
  • 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
  • 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
  • Lead all activities of a group
  • Motivate personnel and resolve conflicts; assume responsible for feedback, performance reviews, hiring and development of staff
  • Perform other duties as assigned
#LI-BS1

Qualification:

  • Ph.D. with 7+ years of experience Analytical Chemistry in the Pharmaceutical Industry, Including 2+ years of management experience
  • Broad understanding of the drug development process, including clinical design, chemical development, solid state development and formulation development, and the interrelationship with analytical development
  • Demonstrated leadership skills and verbal and written communication skills are critical
  • Deep understanding of ICH, FDA and USP guidelines, including the ability to apply the guidelines in context of the stage of pharmaceutical development
  • Excellent interpersonal and team skills
  • Expertise in Parenteral Formulations
  • The ability to work successfully in both a team/matrix environment as well as independently
  • The ability to thrive in a dynamic environment, handle priorities, and maintain timelines for multiple activities

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