Analytical Science and Technology Principal Scientist

Job DescriptionThe Analytical Science and Technology (AS&T) Principal Scientist, potency assay development will be responsible for providing scientific and strategic leadership within and across functional areas for late-stage method development, product development, method validations, and vendor management. S/He will manage the potency method life cycle, including method development, qualification, validation, transfer, and data trending. Additionally, the principal scientist will partner closely with all stakeholders, and with contract testing sites establishing partnerships to ensure compliance with cGMP and Quality Management systems for the global network to deliver our medicines to patients effectively.Key Responsibilities:Responsible for late-stage analytical method development and qualifications to deliver innovative, robust, and fit-for-purpose biological assays for Potency & Impurities testing of proteinsDevelop, optimize, test, transfer, and approve cell-based, ELISA-based, receptor binding assays and methods based on therapeutic mechanisms of action to support the release and stability testing of therapeutic proteinsWork in a cross-functional matrix environment and collaborate with internal Vertex functions including Process Development, Commercial Manufacturing, Regulatory, and Quality teamsResponsible for fractionation of product variants and design and execution of structure-activity relationship and forced degradation studiesBe accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitmentsBe a key contributor to analytical method continuous improvement and lifecycle managementParticipate in troubleshooting and investigations during routine manufacturing and quality control operationsOwn quality events related to methodsSupport regulatory submissions and responses to health agency inquiries for INDs up to and including BLAsAuthor technical documents, such as method SOP, development report, qualification protocols and report, and QBD risk assessmentsWork with CMO/CTO or external partners on method development, product characterization, and technology transfersContribute to method robustness and validation studies, and bioassay reference control strategiesKnowledge and Skills:Demonstrated expertise in analytical method development, qualification, validation, and transfer for biologics productsIn-depth, hands-on experience in cell-based bioassays, immunoassays, ligand binding assays, or similar is a mustDemonstrated expertise in analytical methods for characterization such as Binding kinetics of biological products.Working experience in biologics analytical and CMC development activities required for late-stage and commercialization of products with a good understanding of GMP operation is requiredDemonstrated proficiency with regulatory requirements, USP, and ICH guidelines related to potency assays for registrational filings is requiredExperience in using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required to set method validation criteria and perform DOE based robustness studies are preferred.Excellent communication skills with good technical writing skills with a proven ability to work with internal and external partners is a plusExperience in oversight of CTOs/CMOs for biologics method development, characterization, technology transfer, and Quality TestingAbility to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency.Education and ExperienceBachelor's in Biochemistry, Cell & Molecular Biology, or related disciplineTypically requires 10+ years of relevant professional experience, or the equivalent combination of education and experiencePay Range$129,560 - $194,340Disclosure Statement: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.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.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex 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 select2.

On-Site : work five days per week on-site with ad hoc flexibility.Company InformationVertex 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.

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