Senior Research Associate - Materials/Device Analytical Development

Job Description

Key Activities:

• Design, execute and analyze studies to develop and qualify test methods, demonstrate technological feasibility and characterize material and assembled device products, employing multiple analytical methods (e.g. FTIR, DSC, TGA, mechanical tests for hardness, medical device mechanical testing, viscosity, chromatography, particle size, NGI, autoinjector and pre-filled syringes, and material stress/strain characteristics).
• Enable transfer of assays to QC and provide SME to support for assay qualification, author transfer/qualification protocols and reports.
• Execute test methods in support of device Process Development and Quality activities.
• Troubleshoot, optimize, and trend assay and process performance.
• Management of third party vendors/CRO's.
• Report on project progress, write analytical development protocols and reports, provide recommendations to management
• Identify, qualify, and manage analytical reagents as per regulatory standards.
• Establish design criteria using Design of Experiments (DOE) and other contemporary development tools.
• Perform sufficient statistical analysis to establish specificity, sensitivity, linear range, precision and accuracy of test methods.
• Establish reference standard materials as required to support assay validation.
• Contribute to regulatory submission documents with detailed method descriptions and data analysis.
• Ensure the accuracy and integrity of analytical data generated.
• Maintain excellent written documentation and review (e.g. lab notebook and test forms).

Education Level and/or Relevant Experience(s):

Required:

Bachelor's degree (or equivalent degree) and 2-4 years of experience in analytical development program or other analytical support function, or

Master's degree (or equivalent degree) and 1-2 years of experience in analytical development program or other analytical support function

Knowledge and hands on experience with analytical platforms used for characterization and release assays is required for this position.

Knowledge and Skills (general and technical):

Required:

• Knowledge of at least two of the following methods: FTIR, DSC, TGA, mechanical tests for hardness, medical device mechanical testing, viscosity, chromatography, particle size, NGI, autoinjector and pre-filled syringes, and material stress/strain characteristics (e.g. hardness, viscosity, stress/strain curves).
• Experience in development and validation of analytical methods.
• Strong communication skills for collaboration across teams.
• Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.
• Experience with sample management and electronic documentation systems in the GMP environment.

#LI-onsite

Pay Range:

Disclosure Statement:

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