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Aurion Biotech · 1 day ago

Manager, AS&T

United States

Full-time

Remote

Mid, Senior Level

$153K/yr - $168K/yr

6+ years exp

Aurion Biotech is a clinical-stage biotech company focused on restoring vision through regenerative therapies. The Manager, AS&T is responsible for overseeing quality control deliverables, ensuring compliance with regulatory requirements, and managing method transfers and validations for analytical test methods in a QC setting.

BiopharmaBiotechnologyHealth CareMedical

H1B Sponsor Likely

Responsibilities

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

Qualification

Cell-based assaysMethod qualificationsRegulatory requirementsCGMP knowledgeData integrityAssay method investigationTechnical writingCollaboration skillsAttention to detailDecision making

Required

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

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

Preferred

Additional experience with small molecules is preferred

Additional technical knowledge of Endotoxin testing, PCR, ELISA is preferred

Benefits

We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.

We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.

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.

Company

Aurion Biotech

Aurion Biotech is a clinical stage biotech company, developing a transformational platform of advanced therapies to cure blindness.

Founded in 2021

Seattle, Washington, USA

51-200 employees

https://aurionbiotech.com

H1B Sponsorship

Aurion Biotech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (1)