Associate Director, Drug Product

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September 17

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Immunovant

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Support ongoing drug product formulation and manufacturing at CMO partners • Lead and provide oversight to drug product (DP) process design, including characterization, technology transfer, and robust commercial validation • Serve on cross functional DP work streams and manage DP activities and documents (reviewing/authoring reports, and protocols) through Process Performance Qualification (PPQ) • Provide technical oversight and guide the team to investigate and close out deviations to enable release of manufactured DP batches • Ensure integration of primary filled container closure and component specifications and testing with the combination product design • Work closely with CMC regulatory team and be accountable for DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparations for agency meetings. Author and review regulatory submissions • Effectively/efficiently manage CDMOs and deliver success on drug product supply and BLA filing readiness

🎯 Requirements

• B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Biochemistry, Microbiology, or related field with ten (10) or more years of relevant experience; OR • Advanced degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceutics, Biochemistry, Microbiology, or related field with 5 or more years of relevant experience • Experience with drug product process development, process characterization, technology transfer and scale-up of processes to manufacturing scales of biologics (mAbs or fusion proteins) • Experience with drug product unit operations of manufacturing including freeze/thaw, mixing, filtration, filling and inspection of prefilled syringes • Working knowledge of regulatory requirements for commercialization including application of Quality by Design principles • Working understanding of analytical methods to characterize biologics • Experience with late-stage commercialization of biologics drug-device programs through PPQ and launch • Effective oral and written communication skills. Ability to effectively author or review technical reports, CMC/CTD sections for IND/IMPD, BLA/MAA filings • Ability to effectively articulate understanding of protein and process science to drive decision making on investigations of deviations, impact assessments, design of studies, etc, in a multi-disciplinary team-matrix environment

🏖️ Benefits

• Equity and other forms of compensation may be provided as part of a total compensation package • Full range of medical, dental, vision • 401k • Unlimited paid time off • Parental leave