Senior Scientist, Quality Control

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 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 of Quality Control (QC), you will play a critical role in accomplishing our mission. The Sr. Scientist of Quality Control is primarily responsible for technical oversight of method qualifications and method validations at our external small molecule CDMO. This includes reviewing method qualification and validation protocols, raw data and reports. Additional responsibilities include independently investigating and troubleshooting methods as challenges arise, reference standard qualification, and stability compliance.

KEY RESPONSIBILITIES

• Support QC deliverables for small molecule drug substance development in late-stage clinical development
• Review of outsourced GMP work including method validation, lot release, reference standard program and stability testing for all small molecule drug substance activities
• Ensure all project team deliverables are met for outsourced QC work including lot release, stability testing, method validation/transfer/verification, and reference standard qualification for the small molecule drug substance
• 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
• Review and approve deviations, laboratory investigations, and evaluate proposed analytical change requests
• Maintain flexibility as is phase appropriate
• Other duties as assigned

ABOUT AURION BIOTECH 

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 our success. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit www.aurionbiotech.com

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: Everyone is a shareholder at Aurion Biotech. We offer competitive equity grants, salaries, and bonuses.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

QUALIFICATIONS AND EDUCATION 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• 4+ years experience in Quality Control or other related function with a Master of Science
• 7+ years experience in Quality Control or other related function with a Bachelor’s of Science
• Experience with small molecule 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 small molecule and method validations
• Experience reviewing analytical test results and solving technical problems associated with a wide variety of small molecule QC assays. Specific experience required is HPLC, gas chromatography and Mass spectrometry
• Experience charting data and identifying trends observed during studies
• 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
• Experience with managing QC related deviations, change controls, and laboratory investigations is preferred 
• Small molecule experience required

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES 

• 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?