<p>Job Description</p> <p>Key Activities:</p> <ul> <li>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). </li><li>Enable transfer of assays to QC and provide SME to support for assay qualification, author transfer/qualification protocols and reports. </li><li>Execute test methods in support of device Process Development and Quality activities. </li><li>Troubleshoot, optimize, and trend assay and process performance. </li><li>Management of third party vendors/CRO's. </li><li>Report on project progress, write analytical development protocols and reports, provide recommendations to management </li><li>Identify, qualify, and manage analytical reagents as per regulatory standards. </li><li>Establish design criteria using Design of Experiments (DOE) and other contemporary development tools. </li><li>Perform sufficient statistical analysis to establish specificity, sensitivity, linear range, precision and accuracy of test methods. </li><li>Establish reference standard materials as required to support assay validation. </li><li>Contribute to regulatory submission documents with detailed method descriptions and data analysis. </li><li>Ensure the accuracy and integrity of analytical data generated. </li><li>Maintain excellent written documentation and review (e.g. lab notebook and test forms). </li></ul> <p>Education Level and/or Relevant Experience(s):</p> <p>Required:</p> <p>Bachelor's degree (or equivalent degree) and 2-4 years of experience in analytical development program or other analytical support function, or</p> <p>Master's degree (or equivalent degree) and 1-2 years of experience in analytical development program or other analytical support function</p> <p>Knowledge and hands on experience with analytical platforms used for characterization and release assays is required for this position.</p> <p>Knowledge and Skills (general and technical):</p> <p>Required:</p> <ul> <li>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). </li><li>Experience in development and validation of analytical methods. </li><li>Strong communication skills for collaboration across teams. </li><li>Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team. </li><li>Experience with sample management and electronic documentation systems in the GMP environment. </li></ul> <p>#LI-onsite</p> <p>Pay Range:</p> <p>$74,000 - $110,900</p> <p>Disclosure Statement:</p> <p>The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.</p> <p>At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.</p> <p>Flex Designation:</p> <p>On-Site Designated</p> <p>Flex Eligibility Status:</p> <p>In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.</p> <p>Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.</p> <p>Company Information</p> <p>Vertex is a global biotechnology company that invests in scientific innovation.</p> <p>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.</p> <p>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</p>