Our Manufacturing and Process Sciences group is seeking a Director of Manufacturing. In this critical role, you will be responsible for providing functional leadership to supply chain strategy logistics and warehousing/distribution, manufacturing, facility safety and operations, drug product quality, and employee management.
- 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.
- Must be able to commute to Mountain View.
- Development of manufacturing plan and establishment of standard operating 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.
- Partner with the Clinical Program team to ensure constant supply of released Drug Product.
- 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.
- Provide design input and key stake holder during construction phase and work in tandem with quality to complete commissioning and validation of the GMP manufacturing facility.
- Direct responsibility for GMP facility operations.
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.