Job Description

General Summary:

The Analytical Chemistry Senior Research Scientist designs and executes elaborate analytical experiments for projects and demonstrates resourcefulness in running multiple activities concurrently, all related to achievement of goals/objectives. This role interprets complicated, multidimensional analytical data and makes recommendation on new analytical processes and development directions.

Key Responsibilities:

• Independently designs, conducts, and interprets experiments to continuously improve analytical method understanding, including UPLC/HPLC, Dissolution, and KF titration. Provide technical support in resolving analytical testing issues that arise.
• Develops solid working relationships with relevant technical individuals or teams at contract manufacturing sites.
• Supports method transfer and validation as needed, including drafting protocols, executing experiments, reviewing data packages and reports.
• Initiates and performs lab investigations, works with internal and external labs to identify root causes of quality events, provides scientific-sound solutions, and implements CAPA as needed.
• Prepares and reviews scientific reports and regulatory filings.
• Has flexibility to accommodate changes in responsibilities and project priorities.

Minimum Qualifications:

• BS with 8+ years / MS 5+ years or PhD with 2+ years of relevant work experience
• Quality control experience in chromatographic method validation and transfer, in-process/release/stability testing with a focus on small molecules
• A strong background and in-depth working knowledge of conducting and analyzing data for analytical methods such as UPLC/HPLC, Dissolution, and KF titrations.
• Experience with authoring and reviewing change control documents, deviations, and investigation reports for aberrant results, OOT/OOS, etc.
• Knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical setting
• Excellent technical writing experience such as protocols, reports, and SOPs
• Ability to communicate results and implications of work clearly and effectively
• Demonstrated presentation skills. Advanced written and verbal communication skills

Preferred Qualifications:

• Knowledge of DoE and statistics
• Experience with managing CRO/CMO
• Experience with new product launch

Flex Designation:

Flex Eligibility Status:

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