Director Manufacturing - Cell Culture
Location: West Greenwich, Rhode Island
Posted: October 06, 2016
Reference ID: 353859018
Amgen Rhode Island is one of the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial operations. The site has started a transformational expansion of capabilities and capacity towards a dynamic High Mix/High Volume operation.
We are looking for a Director of Manufacturing to will lead all cell culture/upstream operations. The position reports into the Executive Director of Manufacturing and will provide a unique experience to be part of and shape the transformation of the plant and integrating some of the newest high-yield processing technologies.
The leader will be responsible for 90 staff to ensure plant goals are met and actively represent the manufacturing organization on projects, task forces, site and network teams.
Specific responsibilities include:
Ensure safe and compliant cGMP operations
Leadership, development, and optimization of organization
Contribute to the business results through quality of decisions, results and advice
Develop and implement metrics to track and manage successful, timely accomplishment of assigned goals, objectives and projects
Manage and coordinate resources and personnel to ensure product quality standards and supply plans are met within planned budget
Responsible for conducting all production related investigations, ensuring consistency and compliance with external regulatory requirements
May represent department to regulatory authorities
Prepare and maintain department budget
Analyze and forecast business trends
Work in partnership with management to develop site strategy and plans that support the direction of the company
Work with local and global partner organizations as one team to achieve business goals and to develop innovative solutions
Plan and execute the implementation of major change efforts
Serve as a role model and mentor to purposefully develop talent
Doctorate degree and 4 years of Manufacturing & Operations experience OR
Master's degree and 8 years of Manufacturing & Operations experience OR
Bachelor's degree and 10 years of Manufacturing & Operations experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Currently in a leadership position in a GMP manufacturing plant
7+ years managing teams within a regulated environment
2+ years' experience in applying Operational Excellence and Lean Manufacturing
Cross-functional experience with either Process Development, Quality or Engineering
Technical cell culture experience derived from prior experience in Process Development or Manufacturing
Communication and negotiation skills including executive level communications
Experience in matrixed, cross-site or global network environments
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If 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.