Senior Scientist, Analytical Science & Technology

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Senior Scientist, Analytical Science & Technology

Senior Scientist, Analytical Science & Technology

Fully Remote
• US Remote - WA, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, IN, WI, MS or KY applicants only

Description

Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, WI, MS or WA

Senior Manager, Analytical Science & Technology

$140,000 to $155,000

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.

• 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

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA.

Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship
  :
  We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
• Transformation
  :
  We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
• Grit
  :
  We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years, and this role is key to…