Senior CMC Process Development, Project Manager
Senior Project Manager responsible for cross-functional integration and understanding Process Development activities by developing and maintaining product project schedules across the late stage development and commercialization lifecycle.
Supporting drug substance, drug product, and combination product development programs utilizing structured, systematic methodologies to meet cost and schedule objectives.
Integrating and understanding Process Development activities by developing and maintaining product project timeline across the commercialization lifecycle within Amgens commercial portfolio.
Leading cross-functional teams within Process Development across all modalities and across all commercialization stages as needed. They will partner with technical leads to identify key deliverables, ensure cross functional alignment, and execute plans. They are expected to proactively manage plans to meet deliverables with their teams.
Driving negotiation, decision making, and conflict resolution among team/functional members to accomplish project and business goals.
Partnering with key Product Delivery Team stakeholders, understanding the Clinical Development Plan and strategy to enable alignment with clinical and commercial targets.
Drafting timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions.
Ensuring teams active, aligned communication in functional and cross-functional management reviews and governance meetings.
Driving decision making and communication
Establishing and managing collaboration and team sites. Track delivery and create repositories for all PD deliverables
Project reporting including appropriate risk analysis
Partnering with Business Analytics and functional partners as needed to provide data
Facilitating and incorporating lessons learned, standard methodologies, etc.
Supporting Business Process improvements, including alignment with the Commercialization Office
Doctorate degree and 2 years of Project Management experience
Masters degree and 6 years of Project Management experience
Bachelors degree and 8 years of Project Management experience
Associates degree and 10 years of Project Management experience
High school diploma / GED and 12 years of Project Management experience
Masters degree with 6 years of projects management experience, OR Bachelors degree with 8 years of project management experience.
Minimum of 10 years of experience in the Pharmaceutical, Biotechnology, Medical Devices- Combination Products or other Healthcare related field, direct CMC experience is highly desirable
Ability to foster collaboration and work effectively on cross-functional teams
Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization
Critical thinking and problem-solving skills
Apply standard Project Management tools, and practices; experience with MS Project, Excel and SharePoint highly desirable
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.