Manager, OSD External Product Manufacturing
About the Job
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
BMS is seeking a Manager, OSD External Product Manufacturing\:
- Manages the end to end production of clinical drug product (technical interface through delivery of supplies) using an external network of suppliers with OSD manufacturing capabilities.
- Works collaboratively with colleagues within the internal CSO OSD manufacturing group, with DPST formulators, commercial (GMS) counterparts and cross functional teams engaged in the planning and delivery of sterile drug product for use in clinical trials.
- Participates in technical transfer activities and acts as “person in plant” to monitor batches as required.
- Develops and issues exacting project and technical specifications (in the form of a Statement of Work) to suppliers for all desired services and products.
- Compiles batch documentation that supports the release of finished supplies for clinical use. Liaises with Quality Assurance and analytical laboratories to secure release of finished supplies. Supports and reviews all batch non-conformity reports (quality investigations).
- Strong technical knowledge of OSD manufacturing technology and processing techniques. A minimum of 8-10 years of OSD manufacturing experience. An Engineering degree is preferred.
- Advanced project management skills; Project Management Professional certification preferred.
- Strong verbal and written communication skills required.
- Working knowledge of Master Service, Technical and Quality Agreements.
- Ability to accommodate at least 25% business travel.