Analytical Principal Research Scientist

Key Duties And Responsibilities

Lead by example, fostering a culture of collaboration, innovation, and excellence within the Dissolution Team.
Mentor and guide team members, supporting their professional growth and development.
Actively contribute to creating a positive, inclusive, and high-performing team environment that aligns with Vertex’s core values.

Scientific Contributions

Collaborate with cross-functional teams to design, execute, and interpret dissolution studies to support formulation development and regulatory submissions.
Justification of clinically relevant dissolution method parameters and specifications.
Understanding of key analytical deliverables for late-stage programs including method development, validation, specification setting, stability, release testing and analytical strategies to bring these individual items together collectively for a fast-paced program.
Authoring dissolution sections for regulatory submissions.
Designing validation protocols that are in compliance with ICH and FDA guidelines.
Identifying critical factors/parameters that may not be mandated by guidelines but are essential for developing a robust method and validating it for its intended use.

Problem Solving and Decision Making

Approach challenges with a solution-oriented mindset, leveraging critical thinking and scientific expertise to address complex problems.
Engage in constructive debates and discussions to drive data-driven decision-making and achieve optimal outcomes.

Continuous Learning and Growth

Stay abreast of emerging trends, technologies, and best practices in dissolution science and analytical chemistry.
Proactively seek opportunities for professional development and apply new knowledge to enhance team capabilities.
Demonstrate a commitment to lifelong learning and personal growth, with a focus on developing leadership skills.

Operational Excellence

Work with a sense of urgency to meet project timelines and deliver high-quality results.
Ensure compliance with regulatory guidelines and company policies in all aspects of dissolution testing and reporting.
Contribute to the development and implementation of standard operating procedures (SOPs) and best practices.

Knowledge And Skills

Demonstrated ability to develop solutions to complex problems with creativity and innovation.
Proven teamwork, leadership and collaboration skills, with a demonstrated ability to interact with and influence diverse audiences.
Excellent teamwork, verbal and written communication skills.

Education And Experience

Ph.D. degree in Chemistry, Chemical Engineering or Pharmaceutical Chemistry and 4-7 years experience, or Master’s and 7+ years experience, or Bachelor’s and 10+ years experience.
Demonstrated ability to learn and apply new scientific concepts and techniques.
Strong interpersonal and communication skills, with the ability to foster collaboration and build relationships across teams.
Proven ability to lead, mentor, and inspire team members, with a desire to grow into a managerial role.
A passion for innovation, problem-solving, and driving results in a fast-paced environment.