Career Category

Job Description

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. We are seeking to appoint an experienced leader to assume the role of Senior Manager Manufacturing.  This senior manager will be responsible for a manufacturing support team responsible for new product introductions, product lifecycle management, training, and/or investigations.  This role will leverage continuous improvement, transformative approaches and innovation to drive reliability, efficiency, agility and differentiation.

Scope of Responsibility

The Senior Manager of Manufacturing will be responsible for managing the life cycle and day to day production support requirements associated with the products and process equipment for our Amgen Rhode Island AR5 and AR30 manufacturing facilities.  Specific responsibilities include:

·         Serve on the manufacturing leadership team, including daily management for both plants

·         Provide tactical and strategic management and leadership for operational support and project execution and ensure delivery to short and long-term Amgen Rhode Island site operational goals

·         Build, develop and retain a diverse and high performing team, including coaching and developing staff towards their fullest potential to support an engaged motivated workforce.

·         Effectively collaborate with key customers and support groups (Manufacturing, Quality, Process Development, Engineering, and network partners) and drive new business processes to ensure continuous and sustained improvement.

·         Responsible for product lifecycle management and associated electronic batch records, including all new product introductions and product re-introductions into the plant

·         Responsible for the validation master plan, including strategy, cleaning validation, etc

·         Provide technical support to troubleshoot, identify and resolve process and system issues as needed and manage call coverage for 24/7 operation

·         Manage change controls, corrective actions and preventative actions associated with products and process equipment

·         Own and lead investigations associated with process deviations and non-conformances

·         Deliver results in accordance with cGMP and safety requirements

·         Lead and support regulatory inspections for areas of responsibilities including develop playbooks for the inspections

·         Apply lean principles, strategic thinking and organizational design to maximize department’s efficiency and agility

·         Ensure Business Continuity, identify gaps and develop/implement solutions to close the gaps.

·         Provide exceptional services to plants and site and inform key stakeholders across global operations network during critical activities

Basic Qualifications

·         Doctorate degree and 2 years of Manufacturing & Operations experience

OR

·         Master’s degree and 6 years of Manufacturing & Operations experience

OR

·         Bachelor’s degree and 8 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

Preferred Qualifications

·         Demonstrated managerial experience in a GMP manufacturing plant, preferably a drug substance plant and mammalian cell culture.

·         Demonstrated experience in applying Operational Excellence and Lean Manufacturing

·         Cross-functional work experience in either Process Development, Quality or Engineering

·         Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities

·         Demonstrated ability to forge and maintain strong relationships with other functional areas

·         Ability to effectively develop and coach staff and positively advance the culture of an organization

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.