At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Sr. Manager of Manufacturing, Manufacturing Services
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 other process support operations. 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.
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.
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- 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:
- Plan, develop, and maintain the department budget, minimizing scrap waste in the function.
- Appropriately allocate resources and manage external worker expenses.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative leader with these qualifications.
Basic Qualifications:
- High school diploma / GED and 12 years of biologics and/or GMP manufacturing experience OR
- Associate’s degree and 10 years of biologics and/or GMP manufacturing experience OR
- Bachelor’s degree and 8 years of biologics GMP manufacturing experience OR
- Master’s degree and 6 years of biologics and/or GMP manufacturing experience OR
- Doctorate degree and 2 years of biologics and/or GMP manufacturing experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
- Bachelor’s degree in Engineering, Science, or a related field (Advanced degree preferred).
- 8+ years of experience in a GMP manufacturing environment, with a strong understanding of cGMP regulations.
- 5+ years of leadership experience, with a consistent record of developing and leading successful teams.
- Strong problem-solving skills and the ability to manage complex projects and initiatives.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work effectively across functions and at all levels of the organization.
- Experience with budget management and financial savvy.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for
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