Associate Director - Drug Product Technology

July 25

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Immunovant

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Biotechnology Research

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Description

• Reporting to the Senior Director, Drug Product Technology, this position is responsible for the drug product process technical transfer of biologics • Drive the technical transfer of drug product process of a key biological entity and partner with key Immunovant CMC personnel to ensure success • Perform process transfer, scale-up and lead facility fit activities • Partnering with internal/external teams to ensure process transfer • Apply scientific and engineering principles to support process scale-up fill/finish operations • Utilize product and process knowledge to author Drug Product Process Control Strategy • Review and approve cGMP batch documentation required to support cGMP production • Develop and apply risk-based strategies for process validation throughout product lifecycle • Manage and author SOPs, change controls, deviations and CAPAs • Create/Review relevant technical sections of regulatory dossier or other communications to health authority

Requirements

• Masters or PhD in engineering, chemistry, biological science or another relevant field • Eight to ten years of relevant biopharmaceutical industry experience with experience in process development, technical transfer, process validation, environmental and microbial monitoring, change controls, and manufacturing of biologics • Demonstrated ability to successfully work with and influence contract manufacturing partners • Experience directly working in CMO environment would be preferred • Proven leadership in process engineering, scale-up and process transfer • Ability to work/lead in a dynamic group that takes a multi-disciplined team approach • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results • Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills • Ability to think outside of the box and challenge the status quo • Natural entrepreneurial spirit with unrelenting dedication to delivering results • Desire to work in a fast-paced, innovative environment • Natural collaborator who enjoys working on a cross-functional team

Benefits

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