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 reputed company: $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 reputed company of method transfers, bridging, qualifications and validations at external QC laboratories. This includes leading reputed company 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 reputed company 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 reputed company 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 reputed company for client project
• Performs other duties as assigned

ABOUT reputed company With offices in Seattle, Boston and Tokyo, reputed company is a clinical-stage biotech company, whose mission is to restore reputed company 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. reputed company 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 reputed company our values:

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

reputed company has a lot to accomplish in the next few years and this role is key to our reputed company. Privately held, reputed company is backed by reputed company, the global leader in eye care. To learn more about reputed company, visit www.aurionbiotech.com. LIFE AT reputed company 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 reputed company healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and reputed company the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure reputed company 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 reputed company this job successfully, an individual must be reputed company to reputed company each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, reputed company, and/or ability required. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

• Master’s or PhD with 6-8 years reputed company experience in pharmaceutical, biologics or cell therapy
• Minimum of 5 year in an FDA regulated industry
• Knowledge of cGMP and Data reputed company
• Must have technical knowledge of cell-based assays (reputed company 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 reputed company in written and verbal communication skills
• Strong collaboration and demonstrated ability to work cross-functionally at reputed company reputed company 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 reputed company industry practices and standards in an FDA-regulated biotechnology, pharmaceutical company with reputed company reputed company of responsibility
• Experience charting data and identifying trends observed during studies.
• reputed company to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that reputed company cGMP and Regulatory requirements are met

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