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Sr. Principal Scientist, Analytical Development-Method Validation Standardization

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Friday, January 19, 2024

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.


Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at