Analytical Science and Technology Senior Scientist

Job Description

General Summary:

Vertex is seeking a highly motivated and experienced Senior Scientist to join the Analytical Science and Technology team. In this role, you will work closely with contract manufacturing organizations and a diverse, cross-functional group of scientists at Vertex to solve complex challenges encountered during late-stage development and commercial manufacturing of small-molecule drug products.

The ideal candidate will have a strong scientific foundation and a proven track record of developing, implementing, and troubleshooting analytical methods within the pharmaceutical industry. This individual should thrive in a fast-paced environment and demonstrate the ability to collaborate effectively across cross-functional teams, communicate clearly, and drive solutions to support product development and commercial success.

Key Duties and Responsibilities:

• Designs and performs elaborate and technically challenging analytical experiments in compliance with applicable regulations and SOPs

• Lead analytical method transfer activities for small molecule drug product to CMOs or between internal groups

• Support method validation or co-validation activities for late-phase development and commercial programs

• Prepare, review, and approve technical documentation for commercial products, including analytical methods, SOPs, transfer protocols and reports, laboratory records, and technical reports.

• Serve as the primary analytical lead for external CMOs, overseeing analytical service execution, driving investigations, and partnering on process-related issue resolution

• Analyze and trend commercial data to support continued process verification, identify emerging issues, and inform data-driven decisions.

• Support product lifecycle management activities and implement continuous process improvement through commercial change control

Knowledge and Skills:

• Strong practical analytical chemistry skills across a range of general analytical techniques

• Proven experience in analytical development or technical operations, supporting late-stage development, commercialization and post-approval activities

• Demonstrated expertise in problem-solving and root cause analysis for analytical related issues

• Strong technical knowledge of chromatographic methods, including HPLC, Dissolution, and other analytical techniques commonly used in pharmaceutical analysis

• Experience applying compendial methods such as KF, elemental impurity testing, spectroscopic identification)

• Solid understanding of cGMP regulations, ICH guidelines and CMC regulatory expectations in a pharmaceutical setting

• Proficiency in data analysis, trending and visualization tools to support decision-making and process monitoring

• Strong communication, collaboration and technical writing skills

• Proven ability to work successfully in a fast-paced, matrixed environment while also operating independently with minimal supervision

• Strong project management skills and the flexibility to adjust to shifting project priorities and business needs

Education and Experience:

• Bachelor's, Master's, or PhD in Chemistry, Chemical Engineering, Pharmaceutical Chemistry or other natural science

• Typically requires the following, or the equivalent combination of education and experience: PhD and 3+ years, or Master's and 5+ years, or Bachelor's and 8+ years.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

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 [email protected]