Who we are looking for:

Vor Bio is seeking an experienced Quality Control Senior Analyst who will be responsible for executing activities related to establishment / release / testing of raw materials to support GMP manufacturing activities as well as maintaining critical laboratory materials. The individual will also support the stability program for Vor QC by maintaining schedule / pull dates / inventory and reporting. The individual will support environmental monitoring sample collection and testing and be able to assist with EM data review and data trending. This role will report directly to the Associate Director of Quality Control Critical Materials. The position is onsite, based in Cambridge.

Key areas of responsibility:

• Environmental Monitoring sampling, testing, data review and data trending
• Ensuring stability program is current and aligned with industry requirements and internal SOPs.
• Raw Material program support through interface with external partners, and internal cross functional partners
• Work with SMEs to prepare stability reports and laboratory management to schedule internal and external testing as appropriate.
• Continuous improvement of processes that are within area of knowledge / responsibility.
• Work closely with Process team and receiving site QC to make sure that the analytical method transfer timeline align with process transfer timeline.

Qualifications:

• Bachelor’s or master’s degree in analytical sciences or related fields with minimum 5 years of experience in the development and approval of cell & gene therapy products or biologics or other relevant fields.
• Required experience working in/with clean rooms and proficiency in utilizing aseptic techniques in accordance with industry/compendial standards
• Good communication skills and be able to work cross-functionally with QC, QA, analytical development and CTLs.
• Demonstrated ability to extract scientific details and to multi-task in a high paced environment.
• Experience and knowledge with engineered HSCs and gene editing technologies are preferred.
• Demonstrated collaboration skills working cross functionally, maintain strong stakeholder relationships and influencing scientific rigor.
• Demonstrated ability to draw insights from large data, perform analysis, and present scientific rationale.