Analytical Development Principal Researc

Job Description

Job Description

As a member of the Analytical Development Drug Substance (DS) subject matter expert team this role will support DS process and control strategy development for synthetic small molecule DS programs. Specifically, the individual will help develop new test methods, characterize key samples from DS synthesis development, and leverage these data to collaboratively advance the manufacture of our broad portfolio of potential medicines.

Candidates with extensive hands-on experience with laboratory techniques commonly used in the analysis of small molecule drug substances, especially HPLC and GC, as well as a strong knowledge and understanding of organic chemistry principles, will be best equipped to succeed in this role.

Key Duties and Responsibilities:

• Develop, troubleshoots, and execute a broad range of test methods suitable to determine potency, purity, and stability for drug substances and their precursors.
• Participate in the planning of experiments and provides requisite analytical support to assigned projects with a high degree of reliability and independence.
• Performs initial data review of experimental results and interprets immediate outcomes and/or conclusions within established protocols.
• Tabulate and trend data and collaboratively propose options for impurity and process control.
• Maintains accurate records of experiments and results in an electronic laboratory notebook.
• Demonstrates the ability to present results in both oral and written reports.
• Complies with applicable SOPs.
• Performs other duties as assigned.

Knowledge and Skills

• Experience analyzing samples using HPLC, GC, FT-IR, UV-VIS, KF, and other instruments. Experience with method development for chiral and achiral HPLC is preferred.
• Knowledge of organic chemistry reaction mechanisms and their application to drug substance process development and analytical derivatizations is preferred
• Familiarity with ICH quality guidelines and their application to drug substance development is preferred
• The ability to conduct experiments independently following established methodology and procedures with minimal supervision is... For full info follow application link.

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 Human Resources at ApplicationAssistance@vrtx.com.