Manager, AS&T

Description JOB TITLE: Manager, AS&T LOCATION: Remote candidates based in the following states will be considered: WA, NM, SD, TX, IN, SC, NC, PA, NY, NH, NE, NJ, KY, or MA. REPORTS TO: Associate Director, Quality Control SALARY RANGE: $153,000 to $168,000 ABOUT THE POSITION The primary responsibility of this position is to ensure completion of quality control deliverables in order to meet tech transfer quality project timelines as well as phase 3 and BLA readiness. This individual ensures that the project deliverables are in accordance with Regulatory and Internal requirements. This individual is expected to work closely with the Quality Assurance Leads, Analytical Development Leads and Contract Manufacturing Leads to support Quality team goals. The Manager, AS&T is responsible for providing oversight of method transfers, bridging, qualifications and validations at external QC laboratories. This includes leading all method work and driving deliverables to completion to support phase 3 and BLA submission. In addition to tracking deliverables to completion, this individual will be involved in authoring method qualifications, method validations, and method bridging protocols. Additionally, the AS&T Manager is responsible for independently trending assay validity and investigating and troubleshooting methods as problems arise. This position requires a technically competent quality professional who has experience in cell-based assays in a QC setting. Additional experience with small molecules is preferred. KEY RESPONSIBILITIES The Manager of Analytical, Science and Technology (AS&T) will oversee and manage the activities involved with Technology Transfer, phase 3 readiness, and validation of analytical test methods for cell therapy drug substance and drug products as part of the Quality Control Department supporting the contract manufacturing business unit:

• Serve as the end-to-end technical quality expert, providing strategic quality oversight for DS and DP CMOs.
• Leads analytical QC deliverables across multiple external partners. Track and drive deliverables to completion.
• Responsibilities for design, development, execution, and statistical analysis of validation protocols for analytical, bioanalytical, and compendial methods
• Compile and review assay performance data
• Analyzing and interpreting data, reviewing protocols and reports, investigating analytical problems, and developing approaches to rectify those problems
• Oversees introduction of new analytical equipment and technologies
• Demonstrate strong organizational and technical writing skills
• Act as project lead for client project
• Performs 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 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 & 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.

• Master’s or PhD with 6-8 years related experience in pharmaceutical, biologics or cell therapy
• Minimum of 5 year in an FDA regulated industry
• Knowledge of cGMP and Data Integrity
• Must have technical knowledge of cell-based assays (Flow cytometry, potency, cell count and viability) and regulatory requirements. Additional technical knowledge of Endotoxin testing, PCR, ELISA is preferred.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Proven track record for managing over 12 method qualification or validations across multiple external vendors with a working knowledge of ICH guidelines.
• Experience in assay method investigation
• Demonstrated excellence in written and verbal communication skills
• Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships
• Must have strong attention to detail and demonstrated decision making ability
• Ability to work individually and in a team environment
• Working knowledge of current industry practices and standards in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility
• Experience charting data and identifying trends observed during studies.
• 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

Salary Description$153,000 to $186,000 Apply tot his job Apply To this Job