Senior Scientist, Analytical Science & Technology

Aurion Biotech•Cambridge, MA

6d•Hybrid

About The Position

This position is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy innovation in ophthalmology. As a Senior Scientist, AS&T you will play a critical role in accomplishing our mission. The Sr. Scientist, AS&T is primarily responsible for leading all method transfers and validations at our external CDMO. This includes authoring and reviewing protocols, reviewing raw data and authoring reports. Additional responsibilities include independently investigating and troubleshooting methods as challenges arise, reference standard qualification, and stability compliance.

Requirements

5+ years of experience in Quality Control or other related function with a Master’s Degree (or a PhD with 2 years of relative QC experience). Or 8+ years of experience in Quality Control or other related function with a Bachelor’s Degree
Experience with method validations and USP method verification in late-stage clinical development
Excellent working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH) as they relate to QC testing for cell therapy and method validations
Experience reviewing analytical test results and solving technical problems associated with a wide variety of cell-based QC assays
Must have hands-on experience with and a deep understanding of Flow Cytometry
Experience charting data and identifying trends observed during studies.
Working experience with statistical analysis software (JMP highly preferred) is required
Ability to identify risks associated with method qualifications and validations with a proven track record of resolving challenges as they arise
Demonstrated expertise in analytical method lifecycle management including test method approval, method verification, method validation, and method transfer
Proven ability to interface with CDMOs
Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships
Demonstrated proficiency with managing assigned project deliverables to ensure team success
Strong written and verbal communication skills with ability to summarize scientific data in a logical, organized, clear and persuasive manner
Quality mindset with demonstrated ability to address compliance gaps
Advanced proficiency in use of MS Office products
Ability to work effectively both independently and with other team members

Responsibilities

Support QC deliverables for cellular drug substance and drug product development in late-stage clinical development
Review of outsourced GMP work and serve as Lead SME for method validations, assay control establishment, and method bridging/USP equivalency testing.
Build tools to monitor assay validity and maintain them.
Periodically assess assay validity and investigate as needed
Interface with and build strong collaborative relationships with external stakeholders (CMOs or contract labs) and internal stakeholders including Analytical Development, CMC, and Quality Assurance
Independently resolve technical issues; effectively collaborate with internal and external teams to solve issues with broad scope and/or high complexity
Escalate challenges to management; develop constructive technical proposals and implement solutions for resolution of challenges
Ensure compliance within QC by monitoring test methods, SOPs, and QC analytical data to cGMPs, pharmacopeial, and regulatory requirements
Provide technical support for deviations, laboratory investigations, and evaluate proposed analytical change requests
Authoring and reviewing protocols, reviewing raw data and authoring reports
Maintain flexibility as is phase appropriate
Other duties as assigned