Immunovant, Inc.
Overview
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Role
Associate Director, Drug Product Development. This individual will report to the Executive Director and will be responsible for supporting ongoing drug product formulation and manufacturing at our CMO partners. This role will be a key contributor within the CMC organization, with experience advancing and commercializing biologic drug product programs. The incumbent will be responsible for late-stage commercialization activities of a biologic drug-device product including process scale-up, technology transfer to external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. As a member of the drug product team, the candidate will have a key focus on driving excellence in process characterization, scale-up, transfer, process validation activities and regulatory filing (IND, IMPD, BLA and MAA). Key Responsibilities
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), including registration stability study execution, process characterization planning and execution, tech transfer strategy, PPQ readiness, regulatory filings, PAI (Pre-Approval Inspection) readiness, approval, and launch support Provide technical oversight and use experience to guide the team to investigate and close out deviations in a timely manner 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 the 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 manage CMOs and deliver success on drug product supply and BLA filing readiness Requirements
B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biochemistry, Microbiology, or related field with ten (10) or more years of relevant experience; OR Advanced degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceutics, Biochemistry, Microbiology, or related field with 5 or more years of relevant experience Experience and Skills
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 author or review technical reports, CMC/CTD sections for IND/IMPD, BLA/MAA filings Ability to 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 environment Remote-based Dynamic, interactive, fast-paced, and entrepreneurial environment Travel up to 25% (domestic or international) as required Compensation
Salary range for posting: $185,000 - $195,000 USD. Compensation is based on factors including market location and may vary with knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total package, in addition to a full range of benefits. Equal Opportunity
Immunovant is an equal opportunity employer. We provide a comprehensive benefits package and a work environment that values diversity and inclusion.
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Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Role
Associate Director, Drug Product Development. This individual will report to the Executive Director and will be responsible for supporting ongoing drug product formulation and manufacturing at our CMO partners. This role will be a key contributor within the CMC organization, with experience advancing and commercializing biologic drug product programs. The incumbent will be responsible for late-stage commercialization activities of a biologic drug-device product including process scale-up, technology transfer to external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. As a member of the drug product team, the candidate will have a key focus on driving excellence in process characterization, scale-up, transfer, process validation activities and regulatory filing (IND, IMPD, BLA and MAA). Key Responsibilities
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), including registration stability study execution, process characterization planning and execution, tech transfer strategy, PPQ readiness, regulatory filings, PAI (Pre-Approval Inspection) readiness, approval, and launch support Provide technical oversight and use experience to guide the team to investigate and close out deviations in a timely manner 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 the 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 manage CMOs and deliver success on drug product supply and BLA filing readiness Requirements
B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biochemistry, Microbiology, or related field with ten (10) or more years of relevant experience; OR Advanced degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceutics, Biochemistry, Microbiology, or related field with 5 or more years of relevant experience Experience and Skills
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 author or review technical reports, CMC/CTD sections for IND/IMPD, BLA/MAA filings Ability to 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 environment Remote-based Dynamic, interactive, fast-paced, and entrepreneurial environment Travel up to 25% (domestic or international) as required Compensation
Salary range for posting: $185,000 - $195,000 USD. Compensation is based on factors including market location and may vary with knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total package, in addition to a full range of benefits. Equal Opportunity
Immunovant is an equal opportunity employer. We provide a comprehensive benefits package and a work environment that values diversity and inclusion.
#J-18808-Ljbffr