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 Vertex's 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 Vertex's 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 cGMP's (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:
* 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 0-3 years, or Master's and 3+ years, or Bachelor's 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 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 ApplicationAssistance@vrtx.com