Process Development Associate Director – Commercial Packaging Equipment
| Company | Amgen |
|---|---|
| Location | New Albany, OH, USA |
| Salary | $168903 – $197453 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD, Associate’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Doctorate degree & 3 years of Engineering experience
- OR Master’s degree & 5 years of Engineering experience
- OR Bachelor’s degree & 7 years of Engineering experience
- OR Associate’s degree & 12 years of Engineering experience
- OR High school diploma / GED & 14 years of Engineering experience.
Responsibilities
- Leading the New Product Introduction (NPI) process
- Equipment Characterization and Validation for all GMP equipment and processes at the AOH site
- Provision of technical operations support for the continuous improvement of packaging lines capacity and performance
- Advisory of technical improvement projects
- Ensure effective communication throughout the Amgen commercial site network with all partners
- Support the delivery of productivity, throughput and general capacity improvements across the AOH site by analyzing, designing, and implementing manufacturing and business process improvements
- Manage new process equipment and technology
- Lead the Commissioning, Qualification and Validation of all process and GMP equipment located at AOH
- Own the site master validation plan for GMP equipment and be responsible for the maintenance and execution of this
Preferred Qualifications
- Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
- Proven track record of leading and executing cross-functional projects.
- Strong teamwork, excellent interpersonal and communication skills.
- Direct experience with the manufacturing process for combination products, assembly, label & packaging operations.
- Experience of working with Final Drug Product equipment suppliers.
- Ability to work in a highly regulated and ever changing industry.
- Ability to learn and rapidly adapt to new requirements in a fast moving environment.
- An Operational Excellence approach to work product – driving rapid results.
- A passion to deliver an excellent work product and develop others with an infective positive attitude!