Sr. Manager of Manufacturing, Manufacturing Services

Amgen • West Greenwich, RI

3d • $136,228 - $184,308

About The Position

Join Amgen’s Mission of Serving Patients. 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. 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.

Requirements

• 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
• A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Plan, develop, and maintain the department budget, minimizing scrap waste in the function.
• Appropriately allocate resources and manage external worker expenses.

Benefits

• 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 field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager