Sr. Manager of Manufacturing, Manufacturing Services

Posted:
9/18/2024, 1:57:41 AM

Location(s):
West Greenwich, Rhode Island, United States ⋅ Rhode Island, United States

Experience Level(s):
Senior

Field(s):
Product

Workplace Type:
Remote

Career Category

Operations

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

Live

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:

  • Plan, develop, and maintain the department budget, minimizing scrap waste in the function.

  • Appropriately allocate resources and manage external worker expenses.

Win

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 self-starter 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.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Application deadline

Amgen anticipates accepting applications until 9/6/24; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

141,636.00 USD - 170,171.00 USD