Senior Scientist, Quality Control

Aurion Biotech; United States; Remote; USD 117,000 - 131,000; Full time

Job summary

A leading biotech company is seeking a Senior Scientist in Quality Control. This fully remote role involves overseeing method qualifications and validations, ensuring compliance with regulatory standards, and collaborating with various stakeholders. Ideal candidates will have extensive experience in quality control, particularly in small molecule drug development. The company offers competitive compensation and a vibrant workplace culture.

Benefits

Paid Parking

Team Events

Community Projects

Qualifications

• 4+ years in Quality Control with a Master of Science.
• 7+ years in Quality Control with a Bachelor’s of Science.
• Experience with small molecule method validations.

Responsibilities

• Support QC deliverables for small molecule drug substance development.
• Review outsourced GMP work including method validation.
• Collaborate with external stakeholders and internal teams.

Skills

Analytical Techniques

Communication

Collaboration

Adaptability

Education

Master of Science

Bachelor of Science

Tools

HPLC

Gas Chromatography

Mass Spectrometry

MS Office

Job description

All Jobs > Senior Scientist, Quality Control

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

Full-time

Description

JOB TITLE: Senior Scientist, Quality Control

LOCATION: Remote candidates based in the following states will be considered: IN, MA, NC, NH, NM, NY, PA, SC, SD, TX, or WA.

SALARY RANGE: $117,000 to $131,000. The midpoint of the range is $124,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

This position offers a unique opportunity to join a growing team at the forefront of cell therapy innovation in ophthalmology. As a Senior Scientist of Quality Control (QC), you will oversee method qualifications and validations at our external small molecule CDMO, review protocols, raw data, and reports, and troubleshoot methods as needed.

KEY RESPONSIBILITIES

• Support QC deliverables for small molecule drug substance development in late-stage clinical trials
• Review outsourced GMP work including method validation, lot release, reference standard program, and stability testing
• Ensure project team deliverables are met for all outsourced QC activities
• Collaborate with external stakeholders (CMOs, contract labs) and internal teams (Analytical Development, CMC, Quality Assurance)
• Resolve technical issues independently and collaboratively
• Escalate challenges and develop technical solutions
• Maintain compliance with cGMPs, pharmacopeial, and regulatory standards
• Review deviations, investigations, and change requests
• Maintain flexibility as appropriate for project phase
• Other duties as assigned

ABOUT AURION BIOTECH

Aurion Biotech is a clinical-stage biotech company dedicated to restoring vision through regenerative therapies. With offices in Seattle, Boston, and Tokyo, and backed by Alcon, we value stewardship, transformation, and grit. Our mission is to develop innovative treatments for eye conditions, including our recent regulatory approval in Japan. Learn more at www.aurionbiotech.com.

LIFE AT AURION BIOTECH

We offer comprehensive benefits, competitive compensation, and a vibrant workplace culture with perks like paid parking, team events, and community projects.

QUALIFICATIONS AND EDUCATION

Candidates should have:

• 4+ years in Quality Control or related field with a Master of Science
• 7+ years in Quality Control or related field with a Bachelor’s of Science
• Experience with small molecule method validations and USP verification in late-stage clinical development
• Strong knowledge of cGMP, EMA, FDA, ICH guidelines
• Experience with analytical techniques such as HPLC, gas chromatography, and mass spectrometry
• Ability to analyze data, identify trends, and resolve technical challenges
• Experience managing deviations, change controls, and investigations preferred

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Proven ability to work with CDMOs
• Adaptability and urgency in a dynamic environment
• Strong cross-functional collaboration skills
• Excellent communication skills
• Proficiency in MS Office
• Ability to work independently and in teams