Director of Manufacturing
IGM is a biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer patients. IgM antibodies have inherent properties that we believe may enable them to improve upon the efficacy and safety of IgG antibodies in multiple therapeutic applications.
We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists and targeted cytokines. Our lead product candidate, IGM-2323, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3, and we plan to initiate a Phase 1 clinical trial for the treatment of relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL) patients in 2019. Our second product candidate is expected to be an IgM antibody targeting Death Receptor 5 (DR5).
Our Manufacturing and Process Sciences group is seeking a Director of Manufacturing. In this critical role, you will be responsible providing functional leadership for supply chain strategy, logistics, warehousing/distribution, manufacturing, site safety, quality, and employee engagement.
- B.S. degree in Engineering, Science or related field, and 15+ years in manufacturing biologics.
- Minimum of 5 years of management and leadership experience.
- Knowledge of cGMP manufacturing requirements related to clinical production and commercial manufacturing of injectable products.
- Lean Manufacturing implementation experience.
- Strong leader and mentor.
- Excellent verbal and written communication.
- Extremely well organized with great attention to detail.
- Able to work in a fast-paced, start-up environment.
- “Roll up the sleeves” mentality.
- Development of manufacturing plan and establishment of procedures to ensure high standards of quality, safety, efficiency and schedule compliance.
- Oversee the internal construction of manufacturing capability, while managing ongoing external manufacturing to meet clinical requirements.
- Hire, train, develop and evaluate team. Hold direct reports accountable for performance.
- Partner with Quality and Safety to ensure compliance with quality and safety best practices.
- Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, efficiency.
- Head the RFP and diligence process for all external manufacturing contracts.
- Preparation of CMC documentation for regulatory submissions.
Must be able to travel ~10% of the time.
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.