Career Category

Job Description

About Amgen: 

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

Role Overview:

Effective management of variations (post-launch changes to Amgen’s commercial products) is critical.  This is especially true given the forecasted growth in Amgen’s product portfolio and international expansion.  Drivers of variations vary and include, but are not limited to:  scale up, tech transfer, supplier driven changes required to ensure supply, manufacturing network strategy, new or improved product presentations, test method revisions, regulatory commitments, responses to patient safety issues, and operational excellence projects. 

The Variation Lead is accountable for driving cross-functional execution of a portfolio of variation projects. The Variation Lead partners with impacted stakeholders to further establish the young organization, build high-performing teams, and continually improve the end-to-end variation management process.   Holistically, this group focuses on robust project, portfolio, and process management to capture and accelerate the value of change to our commercial products.

The scope of the variation management process includes: proposal submission, business case development supporting business case governance approval, prioritization within the holistic variation portfolio, project planning, and project execution.

Key Responsibilities:

• Represent the Variation Management Organization (VMO) as a core team member of multiple Product Delivery Teams (PDTs) to guide teams through the process, integrating inputs across Process Development, Regulatory, Supply Chain, Manufacturing, Quality, etc. into cohesive execution and implementation strategies
• Optimize the product’s overall Life Cycle Management strategy to minimizing variation complexity and implementation cycle times
• Lead business case development; a few examples of VMO-led business cases include drug substance/drug product process improvements, drug product expiry extensions, and method revisions
• Lead cross-functional stakeholders 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 execution of a PDT’s portfolio of variation projects (from business case through global regulatory approvals) by ensuring key Technical, Regulatory, and Supply Chain milestones complete per plan
• Partner with stakeholders including Manufacturing sites, Quality Control and External Supply for PDT visibility into upcoming changes; enabling proactive management and implementation of variations
• Communicate priorities to product, functional, and regional stakeholders.  Identify risks and risk mitigation plans, resolve issues, and escalate to appropriate governance as needed.
• Adhere to processes and best practices set by Business Process Owner, drive continuous improvement of processes.  Standardize and integrate project management tools; establish 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%.

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 10 years of Operations or Regulatory experience OR 
• High school diploma / GED and 12 years of Operations or Regulatory experience 

Preferred Qualifications:

• 6 + years biotech or pharmaceutical industry experience
• Able to facilitate and influence senior clients and partners
• Able to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to negotiate a strategic position after taking feedback from multiple sources

Periodic travel to sites required up to 10%.

• Strong project management, problem-solving, and analytical skills; experience with project management tools
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and ensure high-quality results
• Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience driving decision making using DAI principles
• Some experience with a “variation management” process