Manager Manufacturing

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 across a large number of key products for the company.

The Manager Manufacturing is responsible for leading a team in production operations on the manufacturing floor including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities. This role will leverage continuous improvement, transformative approaches and innovation to drive reliability, efficiency, agility and differentiation. The manager will champion a safe and compliant production environment through structured on floor presence.

The initial focus of this role will be part of the Amgen's next-generation manufacturing facility (AR30) startup team on Admin Day shift to prepare the plant for Operational Readiness (up to 6 months). This includes but is not limited to hiring the manufacturing execution team, developing training, revising documentation, and creating strategies to ensure right first time execution on the production floor. After the initial phase, the successful incumbent will be expected to join and lead a shift team working a 12-hour shift. This position is for the day shift. The shift pattern will be 7AM-7PM structure with a rotation covering 7 days per week.

There are multiple positions open.

Responsibilities:

• Ensuring a culture of safety, quality, and continuous improvement while executing the production plan
• Hire and develop a high performing team, build technical and leadership capabilities within the organization to meet current and future business needs
• Drive a culture of continuous improvement
• Deliver strong business results
• Ensures the right people and resources are in place and optimally allocated to achieve results
• Creates an environment that fosters accountability, innovation, continuous improvement, learning and knowledge-sharing
• Ensure effective decision-making
• Responsible for overseeing new technology implementation in manufacturing
• Overseeing the EBR process, including but not limited to MBR creation, revision and day to day manufacturing support
• Overseeing manufacturing validation activities including but not limited to cleaning validation program and the SIP/Autoclave validation program
• Attracting, developing and retaining diverse talent
• Conducts short and long-range planning to ensure readiness of talent to execute future organizational objectives
• Works across functions to build organization and individual capabilities
• Develops strong relationships with staff members, provides open and clear feedback to improve individual and team performance

Basic Qualifications:

• Doctorate Degree
• OR
• Master's Degree and 3 years of Manufacturing and Operations experience
• OR
• Bachelor's Degree and 5 years of Manufacturing and Operations experience
• OR
• Associate's degree and 10 years of Manufacturing and Operations experience
• OR
• High school diploma/GED and 12 years of Manufacturing and Operations experience
• AND
• Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Bachelor's degree in Life Sciences or Engineering
• Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing
• Strong knowledge cleaning and sterilization validation
• In depth experience with New Product Introduction and technology transfer
• Strong leadership and teambuilding skills (coaching, mentoring, counseling)
• Experience with Lean Principles and continuous improvement
• Experience with performance management including conflict resolution and performance reviews
• Analytical problem-solving skills
• Project Management skills
• Thorough understanding of regulatory requirements
• Ability to be flexible and manage change
• Excellent verbal and written communication (technical) skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

Join Us

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.