Senior Quality Assurance Specialist

February 26

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Dianthus Therapeutics, Inc.

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Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

2 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

📋 Description

• As the Senior Quality Assurance Specialist, you will work closely with our CMC team, providing routine QA oversight and support of Contract Manufacturing Organizations and Contract Testing Laboratories. • This is a 6 month contract role reporting to our Manager, Quality Assurance with the potential to extend the contract period. • This role will ensure adequate quality oversight and support of the development, implementation, and maintenance of relevant quality and compliance initiatives in support of Dianthus’s manufacturing efforts and successful execution of clinical trials and global distribution of product. • You must be adept at working both independently and collaboratively with other business verticals including CMC Manufacturing, Supply Chain, Analytical Development, Quality Control, and CMC Regulatory groups. • Experience in Quality Assurance specific to the pharma or biotech industry with knowledge of cGMPs respective to the drug development lifecycle and a comprehensive understanding of regulations and guidelines including ICH, FDA, and EMA is required. • We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.

🎯 Requirements

• 5+ years of experience in CMC Quality Assurance in the pharma or biotech industry. • Minimum of 2 years experience working in small-midsize biotechs. • Exposure to CMC/Pharma Development and development teams. • Experience with biologics preferred. • Experience conducting batch disposition of GMP materials. • Experience working in a pharmaceutical manufacturing environment (aseptic filling experience preferred). • Experience conducting review of analytical test methods and associated raw data. • Experience conducting and/or participating in risk assessments (e.g. FMEA). • Experience in development, oversight, and management of CMO quality relationships. • Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required. • Ability to support the development, implementation, and maintenance of client quality systems including facilitating process improvement activities to the product and project teams. • Working knowledge of cGMPs, ICH, and applicable international regulations and guidelines. • Ability to evaluate and follow-up on quality events, incidents and possible complaints. • Understanding of Quality system reviews, deviations, OOS, change controls, CAPAs, and other remediation plans depending on client needs. • Comprehensive understanding of CFR regulations (21CFR Part 210, 211 etc), ICH guidelines, EMA guidance, quality management systems initiatives, and standards. • Strong attention to detail and the ability to independently prioritize and multitask. • Excellent communication skills, both written and verbal.