Senior Manager, Process Development

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior ManagerProcess Development

What you will do

Lets do this. Lets change the world! In this vital role you will provide scientific and technical leadership within the Process Development Drug Substance Technology group at Amgens FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

• Lead a team of scientists for Product Development Next Generation Laboratory start-up and operation
• Build robust lab scale biologics process models to support tech transfer, commercial process (e.g yield improvement, complex investigation), innovation, and product life cycle management
• Ensure safety and compliance of Process Development activities
• Collaborate with other site-functions and network drug substance teams in delivering plant goals
• Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
• Provide support for regulatory filing, inspection, and other CMC activities
• Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities

What we expect of you

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

• Doctorate Degree and 2 years of biologics Process Development or commercial-scale technical support experience

• Masters Degree and 6 years of biologics Process Development or commercial-scale technical support experience

• Bachelors Degree and 8 years of biologics Process Development or commercial-scale technical support experience

• Associates Degree and 10 years of biologics Process Development or commercial-scale technical support experience

• High School Diploma / GED and 12 years of biologics Process Development or commercial-scale technical support experience

• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

• 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
• 5+ years of management experience
• Strong and in-depth expertise in both cell culture and purification processes
• Experience in process scale-up, technology transfer, troubleshooting, and complex investigation
• Strong oral and verbal communication skills, with the ability to interact effectively with diverse internal and external stakeholders
• Experience developing staff to reach their full potential
• Knowledgeable in regulatory filings and inspections
• Familiarity in operational aspects of commercial biopharma manufacturing
• Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing

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.

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

for a career that defies imagination

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

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.