Senior Director/Technical Advisor, Drug Product jobs in United States
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Immunovant · 2 weeks ago

Senior Director/Technical Advisor, Drug Product

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. The Senior Director, Drug Product will lead formulation and manufacturing process development, technical transfer, and clinical/commercial manufacturing for drug product processes, collaborating with various functional areas to ensure integrated development and manufacturing.

BiopharmaBiotechnologyPharmaceutical
Hiring Manager
Mohammad Ouranus
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Responsibilities

Lead the formulation development, process development, and manufacturing strategies in the design and implementation of stable formulations of monoclonal antibodies for subcutaneous administration via pre-filled syringe and vials
Provide oversight of ongoing drug product production for clinical and commercial processes, ensuring supply continuity
Provide technical and scientific direction to CMOs and external laboratories to ensure project deadlines and performance standards are met
Lead the development/optimization of scalable, efficient, and cost-effective formulation efforts
Responsible for technical leadership in issue resolution with CMO partners, including design of experiments and interpretation of results
Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions
Oversee the development of technical transfer protocols and supervise the transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities
Perform due diligence as needed on potential partners for fit synergies with the current portfolio
Provide oversight to combination product related activities and documentation
Review analytical and clinical data to make scientific conclusions
Maintain current knowledge of regulatory environment, specifically requirements for CMC sections of clinical registration submissions
Create and review technical documents, reports, and presentations for cross functional teams
Manage SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices

Qualification

Drug product manufacturingFormulation developmentBiologics experienceRegulatory knowledgeTechnical leadershipProblem-solvingCommunication skillsNegotiation skillsTeam collaboration

Required

PhD with 6+ years of experience, Masters with 10+ years of experience, or Bachelors with 12+ year of experience in pharmaceutical sciences, biochemistry or another relevant field
Relevant biopharmaceutical industry experience with experience in drug product manufacturing of biologics (monoclonal antibodies preferred) for subcutaneous administration
Depth of experience in formulation and drug product process development of biologics delivered subcutaneously
Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship
Proven leadership in management of CMO production
Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals
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 a total compensation package
Full range of medical, dental, vision, 401k
Unlimited paid time off
Parental leave

Company

Immunovant

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Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases.

Funding

Current Stage
Public Company
Total Funding
$1.86B
Key Investors
Roivant Sciences
2025-12-11Post Ipo Equity· $550M
2025-01-13Post Ipo Equity· $450M
2023-09-27Post Ipo Equity· $450M

Leadership Team

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Melanie Gloria
Chief Operating Officer
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Company data provided by crunchbase