Job Description

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 & 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 establishing partnerships 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 & 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 report, method bridging and risk assessments.
• Work with CMO/CTO or external partners on work request, 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 variety of separation and detection modes), electrophoretic (CE and IEF) separation or impurity methods for biologics is a must.
• Familiarity with the GMP, CLP, and regulatory guidance such as ICH, USP/EP/JP as applicable to analytical methods and commercial-stage CMC. 
• Familiar with analytical methods for biological products characterization including but not limited to peptide mapping and MS is a plus.
• Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines related to potency assays for registrational filings is required.
• Experience in statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required for data analysis and generating plots is desired.
• Excellent communication skills with good technical writing skills with a proven ability to work with internal and external partners is a plus.
• 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.
• Typically requires the following, or the equivalent combination of education and experience: PhD and 5+ years, or Master's and 8+ years, or Bachelor's and 10+ years of relevant work experience.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex 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 select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

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 [email protected]