Process Development Scientist-DP Technology Transfer
What you will do
Lets do this! Lets change the world. In this vital role you will work as a Process Development Scientist to support the AML PD DP NPI Organization. This group leads AML DP new product introductions and product lifecycle projects. The Scientist will support the business case process and project implementation for the NPI Organization.
Responsibilities may include:
- Develops business cases for new product introduction and product lifecycle projects. Including technical and financial requirements.
- Lead all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
- Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
- Assess project issues and develop solutions to meet scientific efficiency, quality and client satisfaction goals and objectives.
- Assist in technical, financial, and organizational issues by researching issues, providing recommendations, and maintaining document archives.
- Manage and supervise project budget(s).
- Negotiate and reconcile the use of resources for the projects.
- Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
- Develop and implement tools, techniques, and processes to provide or build information to enable informed decision making within the teams.
- Actively participate in leading the evolution and defining the role of the project
- Ensure the project goals and objects are well understood by the various functional areas.
- Liaison with Management, Department Heads, Leaders, sub team leaders and members to acquire their continued input and feedback on the benefits, needs, and issues associated with the project.
- Maintain the master project plan and schedule for assigned projects.
- Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
- Ensure project work stays in sync with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
- Ensure project work aligns with practices, policies and standard operating procedures.
- Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
- Anticipate resource needs and communicate to management sponsors
- Develop and manage change controls in Trackwise system
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Process Development Scientist professional we seek is an individual contributor with these qualifications.
Masters degree & 3 years of Manufacturing support experience in a GMP regulated industry
Bachelors degree & 5 years of Manufacturing support experience in a GMP regulated industry
Associates degree and 10 years of Manufacturing support experience in a GMP regulated industry
High school diploma / GED and 12 years of Manufacturing support experience in a GMP regulated industry experience
Beyond that, additional preferred qualifications are:
- Educational background in Life Science or Engineering is preferred.
- Understanding and experience with Ariba Sourcing and Contracting Modules. Experience with SAP, Trackwise and Project management tools preferred.
- Skills in prioritizing multiple responsibilities, priorities, tasks, and projects simultaneously.
- Practical project management software and spreadsheet skills, proficient computer operation skills.
- Good organizational skills, detailed & accurate, analytical skills.
- Must be a great teammate, self-starter, strategic problem solver, persistent, tactful, and persuasive.
- Proficient in the English and Spanish language (written and oral).
- Highly proficient with MS Office, including Excel, Word and PowerPoint.
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear. Join us.careers.amgen.com
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.