Director, Commercial Drug Products & Cycle Management

Director, Commercial Drug Products & Life Cycle Management

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At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. 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.

Director, Commercial Drug Products & Life Cycle Management

What You Will Do

Let’s do this. Let’s change the world. In this vital role you will be part of Amgen’s Process Development organization, Drug Product Technologies unit that continuously strives to be a technical leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products.

• Provide scientific, technical and managerial leadership in support of commercial drug product and life cycle management activities.
• Lead a team of highly skilled scientists and engineers with advanced degrees and training and lead the strategic direction of the group to ensure contract book deliverables for the portfolio, aware of industry trends, future requirements and feedback from key partners.
• Provide technical leadership to influence and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, biosimilars, and oral dosage forms.
• Maintain strong partnerships with product delivery team leaders in Operations, Therapeutic Area heads, all Process Development groups, Regulatory, Quality and with Clinical and Commercial manufacturing sites to positively influence Amgen practices and strategies to ensure success through the life cycle of current and future commercial products.
• Advance the organization’s competence on GMP compliance, current regulatory trends and expectations.
• Actively direct and lead team capacity/resources, budget targets, timelines.
• Talent management responsibilities including hiring, leadership development, mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment.
• Recruit and retain technical staff that can deliver in a highly matrixed and dynamic environment.
• Up to 25% travel to domestic and international sites.

What We Expect Of You

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

Basic Qualifications:

• Doctorate degree and 4 years of experience in engineering, science, or business management
• Or Masters degree and 8 years of experience in engineering, science, or business management
• Or Bachelors degree and 10 years of experience in engineering, science, or business management
• And In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Preferred Qualifications:

• PhD from an accredited college or university in one of the following areas:
  Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area
• 10+ years of pharmaceutical development and management experience
• 10+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization
• Demonstrated knowledge of drug product commercialization and integrated combination product development
• Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at…