Career Category

Job Description

Manager Manufacturing

The Manufacturing Manager position is within the Purification organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. This position offers the opportunity to collaborate with multiple functions on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility and site.

With minimal direction, the manager is responsible for leading on the floor operations and staff in manufacturing. This individual will be responsible for supervising, mentor, hiring, and development of floor staff. The front-line manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts. The manager will need to effectively advise his/her team and deliver on short and long term Amgen Operational goals and will work closely with a second area FLM to manage the operations for the day.

Scope of Responsibility

• Demonstrate technical mastery of purification processes
• Ensure safe working environment.
• Ensure cGMP and CFR compliance of operating areas.
• Resolve problems during operation. Elevate critical and impactful events to Sr. management and make real time processing decisions.
• Participate as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.
• Develop, implement and assess solutions for sophisticated problems.
• Ensure scheduling of production and maintenance activities. Collaborate with cross-functional teams (i.e. QA/QC, F&E, PD, Regulatory, etc.) in completing production activities and ensuring schedule adherence.
• Interact with business partners and internal/external audit teams including regulatory agencies as advised
• Ensure effective decision-making and clear and timely communication

Leading Strategy Development and Execution

• Assists in developing and implementing departmental strategy and plans that are aligned with the broader organizational strategy
• Anticipates risk and builds contingencies to help mitigate impact
• Deliver strong business results

Building a Strong Organizational Alignment

• Responsible for selection training, evaluation, staff relations and development of staff.
• Interacts with management in optimizing organizational structure and responsibilities.
• 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
• Builds and develops a diverse, robust team
• Works across functions to build organization and individual capabilities
• Develops positive relationships with staff members, provides open and clear feedback to improve individual and team performance

Shift: 7:00am - 7:00pm rotating days

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 leadership and teambuilding skills (coaching, mentoring, counseling)
• Experience with staff capability and team performance improvements
• Experience with performance management including performance reviews
• Conflict Resolution skills
• Analytical problem solving skills
• Project Management skills
• Detailed understanding of regulatory requirements
• Ability to be flexible and manage change
• Excellent verbal and written communication (technical) skills
• Excellent digital literacy with Microsoft, EBR/MES, Delta V, Electronic quality systems.