Supply Chain Manager - Variation Lead

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

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. 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.

Supply Chain Manager - Variation Lead

What you will do

Let’s do this! Let’s change the world! Effective management of post-approval changes (variations) to Amgen’s commercial products is critical. This is especially true given the forecasted growth in Amgen’s product portfolio and international expansion. In this pivotal role, you will be accountable for driving the cross-functional strategy and implementation of a portfolio of post-approval changes. The Variation Lead partners with impacted customers to further establish the young organization, build impactful teams, and continually improve the end-to-end variation management process.

• Represent the Variation Management Organization (VMO) as a core team member of multiple Product Delivery Teams (PDTs) to guide teams through the variation process, integrating inputs across Process Development, Regulatory, Supply Chain, Manufacturing, Quality, etc. into cohesive implementation strategies

• Execute to the product strategy, optimizing the product’s overall Life Cycle Management to minimize variation complexity, implementation cycle times, and risk

• Lead business case development including financial analysis, execution strategy, and risk management; a few examples of VMO-led cases include drug substance/drug product process improvements, drug product expiry extensions, and method revisions

• Lead cross-functional team members in development of variation project plans (defining required technical activities, change control strategy, supply strategy, and regulatory strategy through submission and approval from global regulatory agencies)

• Drive end-to-end strategy and execution of a PDT’s portfolio of variation projects (from business case through global regulatory approvals) by ensuring key Technical, Regulatory, and Supply Chain deliverables are completed per plan

• Partner with collaborators, including Manufacturing sites, Quality Control, and External Supply for PDT access to upcoming changes; enabling proactive management and implementation of variations

• Communicate priorities to product, functional, and regional collaborators. Identify risks and risk mitigation plans, resolve issues, and advance through appropriate governance as needed.

• Adhere to processes and standard methodologies set by Business Process Owner and drive continuous improvement of processes. Standardize and integrate project management tools; establish a single source of truth for variation status.

• Shepard variations through the governance process

• Lead the Variation Execution Team (VET) meeting within Supply Chain to ensure dynamic Regional inputs and constraints are reflected in the Global Supply transitions plan

• Periodic travel to sites required up to 10%.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 2 years of Operations or Regulatory experience OR

• Bachelor’s degree and 4 years of Operations or Regulatory experience OR

• Associate’s degree and 8 years of Operations or Regulatory experience OR

• High school diploma / GED and 10 years of Operations or Regulatory experience

Preferred Qualifications:

• Project management, problem-solving, and analytical skills; experience with project management tools

• Demonstrated ability to lead cross-functional teams, consistently deliver timely, and ensure high-quality results

• Collaborates and communicates well with others, able to balance divergent inputs from various collaborators and drive issue resolution

• Ability to operate in a matrixed or team environment with the site, functional, and executive leadership

• Experience driving decision-making using DAI principles

• Some experience with a “variation management” process

• Knowledge of systems: Tableau, SmartSheets and other digital tools

What you can expect from 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 field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

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

Apply now

for a career that defies imagination

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

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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. 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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