Analytical Science and Technology Principal Scientist

Job Description

The 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 proteins

• Develop, 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 proteins

• Work in a cross-functional matrix environment and collaborate with internal Vertex functions including Process Development, Commercial Manufacturing, Regulatory, and Quality teams

• Responsible for fractionation of product variants and design and execution of structure-activity relationship and forced degradation studies

• Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments

• Be a key contributor to analytical method continuous improvement and lifecycle management

• Participate in troubleshooting and investigations during routine manufacturing and quality control operations

• Own quality events related to methods

• Support regulatory submissions and responses to health agency inquiries for INDs up to and including BLAs

• Author technical documents, such as method SOP, development report, qualification protocols and report, and QBD risk assessments

• Work with CMO/CTO or external partners on method development, product characterization, and technology transfers

• Contribute to method robustness and validation studies, and bioassay reference control strategies

Knowledge and Skills:

• Demonstrated expertise in analytical method development, qualification, validation, and transfer for biologics products

• In-depth, hands-on experience in cell-based bioassays, immunoassays, ligand binding assays, or similar is a must

• Demonstrated 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 required

• Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines related to potency assays for registrational filings is required

• Experience 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 plus

• Experience in oversight of CTOs/CMOs for biologics method development, characterization, technology transfer, and Quality Testing

• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency.

Education and Experience

• Bachelor's in Biochemistry, Cell & Molecular Biology, or related discipline 

• Typically requires 10+ years of relevant professional experience, or the equivalent combination of education and experience

Pay Range

$129,560 - $194,340

Pay Range:

$129,560 - $194,340

Disclosure Statement:

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

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. 
 

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]