Description
JOB TITLE: Senior Scientist, Quality Control Operations
LOCATION: 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 or WA.
REPORTS TO: Senior Manager, Quality Control
SALARY RANGE: $112,000 to $131,000
ABOUT THE POSITION
This is a newly created role at Aurion Biotech within the Quality Control Department. The primary responsibility of this position is to support completion of quality control deliverables in order to meet quality project timelines, ensuring that the delivery is in accordance with Regulatory and Internal requirements. This individual is expected to work closely with the Quality Assurance leads and CMC Leads to deliver Quality team goals.
KEY RESPONSIBILITIES
- Works with external QC laboratories to review and track GMP in process, release and stability testing
- Real time review of DP release data during harvests and CoAs as part of a rapid release strategy.
- Leads QC data compilation and shares in cross-functional settings.
- Able to work with CMO on out-of-specifications and investigations as needed.
- Designs DS and DP stability studies, leading to establishment of expiry. This includes protocol review, data review, and report review in collaboration with an external CMO.
- Supports technology transfers through data and document review.
- Participates in internal and external collaborations to ensure project deliverables are complete and on time by providing team updates and enabling data-driven decisions.
- Works collaboratively and cross-functionally to support and implement activities to ensure the project milestones are met.
- Be able to help support regulatory personnel with supportive documents related to regulatory filings.
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 Alcon, the global leader in eye care. 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: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
- 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.
Requirements
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.
- MS degree 5+ years’ experience, or a BS degree and 10+ years’ experience in a relevant discipline (cell biology, biotechnology, or related field) in the pharmaceutical industry.
- Experience with biological products is critical, experience within cell therapy is preferred but not required.
- Working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH, USP, JP) .
- Experience working within a QC pharmaceutical laboratory.
- Experience in lead roles is preferred but not required.
REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES
- Detail oriented and effective time management.
- Ability to work cross-functionally with excellent verbal communication and collaboration skills
- Quality mindset with demonstrated ability to identify compliance gaps
- Proficient use of MS Office products
- Ability to use Smartsheet is preferred, but not required
- Ability to adapt to rapid changes and work in a fast-paced team environment.
- Ability to work effectively both independently and with other team members.
- Ability to travel to CMO locations as needed.
- Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
Salary Description
$112,000 to $131,000
