Amgen Job Description This high level position for a subject matter expert within the Product and Process Engineering Organization is responsible for providing scientific and technical leadership and strategic direction to the evaluation of designated raw materials, in this case plastics used in single use biopharmaceutical applications, and their potential impact on product quality and process performance. Responsible to assess the impact of changes in materials or manufacturing processes.
This individual will be responsible for assessing supplier capabilities, technical competences and understanding of the needs of biopharmaceutical manufacturers along with other team members. The successful candidate will support or lead cross-functional teams of experienced scientists and engineers through project challenges and mentor them in the selection of the most appropriate materials and technologies. The candidate will actively chart the course and translate business strategies into challenging, actionable objectives and plans, and will apply meaningful metrics for projects, personnel and other resources. Basic Qualifications • Doctorate degree & 2 years of directly related experience
- Master’s degree & 6 years of directly related experience
- Bachelor’s degree & 8 years of directly related experience
- Associate’s degree & 10 years of directly related experience
Should be willing to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas.
- High school diploma / GED & 12 years of directly related experience Preferred Qualifications • PhD in materials science with specialization in polymers, or multiple years in the manufacture of pharmaceutical plastics
- Ten years relevant work experience in use of plastics materials in biopharmaceutical applications
- Knowledge of license applications and the drug development process
- Familiarity with all aspects of the use of plastics in biopharmaceutical applications, current state of the art technologies and emerging scientific directions.
- Leadership experience of progressively increased scope.
- Strong interdisciplinary project management skills.
- Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects.
- Should be recognized in the scientific community and supplier base through a sustained record of publications and patents.
- Should have strong communication skills, both written and oral. He/she must network and build solid working relationships across departments, with diverse and remote staff and with external collaborators from key suppliers.
- Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans.
- Team leadership, management, and facilitation skills preferred.
- Extensive knowledge of the manufacturing processes, usage, regulatory requirements, practices, scientific properties and risks associated with the raw materials for pharmaceutical and biological products.
Amgen - 2 years ago
Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...