Department: Azzur Cleanrooms On Demand San Diego LLC
- Scheduling, planning, and management of COD projects nationwide to enable client tech transfers, new site implementations etc
- Work with various COD sites nationwide to develop finite schedules for each site which will feed into a global project schedule.
- Work with site client operations to develop and maintain tech transfer schedules for all COD sites.
- Develop, maintain and manage new site implementation project schedules for all new COD sites and expansions.
- Plan and deploy resources for all non-routine operations such as tech transfers and new site implementations at various COD sites.
- Manage junior staff that is part of the global tech transfer pool of resources.
- Work with other areas within Azzur Group or third parties to coordinate activities related to tech transfers and new site implementations (i.e. Consulting, ATS, Labs etc.).
- Develop and maintain global COD tech transfer business processes and documentation.
- Bachelor’s Degree in a scientific discipline, preferably engineering or life sciences.
Required Work Experience:
- A minimum of 5 years of experience in the biopharma industry with at least 3 years of direct project management experience
- Demonstrated project management experience in new facility start-ups, CQV, or multi-site projects is a must.
- Experience with capital projects and budget management, financing, and related activities.
- Experience in facility, utilities, equipment, and system (FUSE) qualification.
- Experience with facility shutdown and changeover activities.
- Experience with small-scale process development or biopharma manufacturing experience.
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Growth Opportunities
- 401(k) match
- Medical Benefits
- Paid Holidays
The Cleanrooms On-Demand model is an alternative to building out new cleanrooms or utilizing a CMO. Our clients utilize the cleanroom space and facility infrastructure (such as EM, waste management, security, etc.) with the option to add on additional services as needed while maintaining ownership of their IP and their process. In essence, we provide the GMP envelope around the clinical manufacturing activities that our clients perform in our cleanrooms. The goal for our clients is an accelerated timeline to clinic, flexibility, and cost savings.
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.