Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Verte[...]

General Summary The Analytical Science and Technology (AS&T) Principal Scientist, Separation Method Expert, will be responsible for providing scientific and technical expertise within and across functional areas for late-stage and commercial methods and vendor management. S/He will manage the method life cycle, including method remediation, validation, transfer, troubleshooting and investigations for OOT/OOS, along with data trending analysis. Additionally, the principal scientist will partner closely with all stakeholders and with contract testing sites to ensure compliance with cGMP and Quality Management systems for the global network to deliver our medicines to patients effectively. Key Duties and Responsibilities Lead analytical method remediation, validation and transfer for separation methods used for late stage and commercial Biologics programs. Lead and support troubleshooting and investigations for in-process, release and stability testing. Own Quality events and analytical related activities (Change Controls, Impact Assessments, Change Actions) related to analytical methods and related activities. Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for worldwide commercialization and ongoing product lifecycle activities. Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments. Support regulatory submissions and responses to inquiries from health agencies for INDs and BLAs for Biologics as analytical method Subject Matter Expert (SME). Author technical documents, such as method SOPs, method validation/transfer protocols and reports, method bridging and risk assessments. Work with CMO/CTO or external partners on work requests, product characterization, and technology transfers. Review method trending data and prepare APQRs. Knowledge and Skills Demonstrated expertise in analytical method development, validation, transfer and lifecycle management for protein-based biologics products. In-depth, hands‑on experience in separation methods including chromatographic (with a variety of separation and detection modes), electrophoretic (CE and IEF), separation or impurity methods for biologics. Familiarity with GMP, CLP, and regulatory guidance such as ICH, USP/EP/JP as applicable to analytical methods and commercial‑stage CMC. Experience with analytical methods for biological products characterization including peptide mapping and MS is a plus. Proficiency with regulatory requirements, USP, and ICH guidelines related to potency assays for registrational filings. Experience in statistical analysis tools (e.g., JMP) and knowledge of statistical concepts for data analysis and plot generation. Excellent communication skills and technical writing proficiency. Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency. Education and Experience PhD, Master’s or Bachelor’s in Biochemistry, Chemical engineering, or a related discipline. Requirements: PhD and 5+ years of experience, or Master's and 8+ years, or Bachelor's and 10+ years of relevant work experience. Compensation $138,400 - $207,600. The range represents an estimate for the base salary 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. Benefits Inclusive market‑leading benefits to meet learning, financial, family and wellbeing needs. Benefits include medical, dental and vision coverage; generous paid time off (including annual company shutdowns); educational assistance programs; student loan repayment assistance; commuting subsidies; charitable donation matching; 401(k); and other mandatory benefits. Benefits are mandatory for mandatory mandates and mandatory mandates. Flexibility Hybrid‑Eligible or On‑Site Eligible. In this Hybrid‑Eligible role, you may work remotely up to two days per week or work five days on‑site with ad hoc flexibility. Equal Employment Opportunity Statement 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 must request it through the recruiter or hiring manager. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)