Director of Manufacturing
Currently working with a Global Biotech Client who are in need of support from a Director of Manufacturing in Massachusetts, U.S. This is an opportunity to work with a global leader in Cell and Gene therapy transforming healthcare with ground-breaking technology.
Interview + offer will take place this week and next, so get in touch ASAP if interested.
Responsibilities:
- Ensure site manufacturing activities are scheduled and run in accordance with company goals and objectives.
- Certifies pharmaceutical product is manufactured in a timely and compliant manner according to GMP requirements for clinical trials of IND and approved NDA materials.
- Review manufacturing process performance data to assess if processes are operating as expected.
- Collaborates with Process Development, Engineering and MSAT for the transfer and implementation of new technologies.
- Ensures departmental plans and resources are efficiently utilized so products are produced in accordance with planned manufacturing batch production schedules.
- Participates in development of operating plans and budgets
- Supports development of CMC regulatory filings related to the Manufacturing facility.
- Responsible for continuous improvement and prioritization of Quality efforts in order to ensure compliance.
- Creates vision and inspires team on a unified operating strategy to ensure short and long term success.
- Set goals and objectives to for organization in alignment with supporting functions.
Requirements:
- BS in scientific discipline
- 10+ years of relevant experience in a manufacturing environment, preferably a biopharma discipline
- 8+ years of experience in managing an operations group or equivalent
- Solid understanding of quality fundamentals, quality control, and quality management systems
- Experience in internal and external audits
Position: Director of Manufacturing
Location: MA, United States
Start Date: Immediately or by agreement