Analytical Science and Technology Sr. Scientist

Job Description

Job Description

Vertex is seeking a talented experienced analytical chemist for late-stage product development in a commercial setting with an interest in Process Excellence. Working directly with our contract manufacturing organizations and a highly diverse group of scientists at Vertex you will solve complex problems encountered in commercial production/manufacturing of drug products. You will be part of an organization that thrives on innovation and is at the forefront of implementing Quality by Design and Continuous Manufacturing. To be considered for this position the applicant will need to be a collaborative experienced and competent analytical chemist with a history of developing implementing and troubleshooting analytical methods in the pharmaceutical industry with the ability to influence colleagues and possessing strong communication and negotiation skills. Experience in developing process maps and implementing sustainable process improvements is desired.

Key Responsibilities
Manage method transfers for small molecule drug product and drug product intermediate to various CMOs to support late-phase and commercial projects
Author/review documentation to support new and existing commercial products (methods SOPs transfer protocols/reports technical reports etc.)
Manage commercial QC testing at Vertexs Contract Testing Organizations
Conduct technical review of analytical data (QC release and stability testing)
Lead analytical OOS/OOT investigations and assist process investigations
Perform statistical analysis for continued process verification
Partner with MS&T Supply Chain Quality and Regulatory to lead the coordination of activities in support of Vertexs commercial drug product and drug product intermediate manufacturing
Manage analytical method lifecycle (method performance trending process improvement change control)

Knowledge and Skills:
Experience in an analytical development or technical operations role supporting new product development and/or commercialization
Problem-solving/root cause analysis for analytical related issues
Experience with chromatography methods such as HPLC GC and other common analytical techniques used in pharmaceutical analysis
Experience with compendial methods for analysis (e.g. KF elemental impurity testing and identification by spectroscopy)
Knowledge of cGMPs (e.g. Quality Control) ICH guidelines and associated CMC regulatory considerations in a pharmaceutical setting
Proficient with data analytics and visualization tools
Strong communication and technical writing skills
The ability to work successfully in both a team/matrix environment as well as independently
Demonstrated ability to effectively manage project(s) and flexibility to accommodate changes in responsibilities or project priorities

Education and Experience:
Bachelors Masters 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 0-3 years or Masters and 3 years or Bachelors and 6 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 Vertexs 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 persons 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