Sr. Manager of Manufacturing, Manufacturing Services

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Senior Manager of Manufacturing, Manufacturing Services

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What you will do

Let’s do this! Let’s change the world! In this vital role you will lead our Manufacturing Services team. This role is accountable for ensuring the safe, compliant, and efficient operations within Raw Material Weigh and Dispense and Equipment Prep areas. The Sr. Manager will oversee all activities associated with GMP support of manufacturing areas and equipment, ensuring they meet current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations. This role is essential to maintaining the safety, purity, quality, and effectiveness of our products while fostering a high-performance team culture aligned with Amgen’s leadership attributes.

Key Responsibilities:

General:

• Oversee and ensure all GMP support manufacturing activities are conducted in a compliant, agile, and cost-effective manner.

• Ensure that products are manufactured, tested, stored, and distributed according to cGMP, GDP, and other applicable regulations and specifications.

• Lead investigations, corrective actions, and preventative actions associated with process deviations/non-conformances, adapting strategies as needed to maintain high standards of quality and compliance.

• Identify, assess, and mitigate risks to ensure the safety, purity, quality, and effectiveness of manufactured products, developing contingencies to address potential challenges.

• Develop a successful team, building technical and leadership capabilities to meet current and future business needs.

• Ensure controlled documents for the area of responsibility are maintained, with active owners assigned for periodic reviews.

• Alert senior management of significant quality, compliance, supply, and safety risks.

• Accountable for the functional key performance indicators and evaluations for Management Reviews.

• Plan and oversee GMP activities for assigned areas.

• Support and drive Continuous Improvement initiatives, programs, and projects.

• Serve as the subject matter expert for the functional area during health authority inspections.

Leading Strategy Development and Execution:

• Develop and implement departmental strategies and plans that align with the broader site strategy.

• Champion functional transformation and institutionalize best practices in processes, practices, business models, and governance.

• Anticipate risks and build contingencies to mitigate their impact, ensuring timely and effective responses to challenges.

• Deliver strong business results and be accountable for functional key performance indicators.

• Lead and/or participate in Amgen network initiatives.

Building Strong Organizational Alignment:

• Demonstrate personal credibility and build strong working relationships across organizational and geographical boundaries.

• Ensure the right people and resources are in place and optimally allocated to achieve results.

• Foster an environment that encourages accountability, innovation, continuous improvement, learning, and knowledge-sharing.

• Ensure effective decision-making and clear, timely communication across the organization.

• Ensure an adequate number of personnel with appropriate education, experience, and training in accordance with cGMP requirements.

Attracting, Developing, and Retaining Diverse Talent:

• Continue to build the Manufacturing Services organization into a successful team that embraces our differences and sustains a culture of inclusion and belonging.

• Conduct talent succession planning to ensure readiness of talent for future organizational needs.

• Establish an efficient and effective organizational structure with clearly defined roles and responsibilities.

• Develop strong relationships with staff, providing open and clear feedback to improve individual and team performance.

Delivering Financial Commitments: