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 (ChangeControls, Impact Assessments, Change Actions)related toanalytical 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 orimpuritymethods 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, Master9;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:
$138,400 - $207,600
Disclosure 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 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 Vertex9s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
