Process Development Drug Product Senior Engineer at Amgen

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Drug Product Senior Engineer

Lets do this. Lets change the world. In this vital role you will work as part of the global Process Development organization supporting manufacturing at various drug product contract manufacturing sites, globally. Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production.

• Act as a drug product technical authority, to provide leadership and solutions when troubleshooting oral solid drug product manufacturing, for all unit operations including but not limited to encapsulation, blending, milling, granulation, drying, compaction and coating.
• Build excellent business relationships with Contract Manufacturing partners, Global Operations, Contract Manufacturing Quality, and Drug Product process teams.
• Demonstrate the ability to lead, via cross-site teams, and in general by setting the agenda and identifying potential issues.
• Provide process development expertise for commercial drug product processing in specific areas such process characterization, technology transfer, process validation and routine commercial production.
• Tackle issues with drug product processing technologies and equipment.
• Identify and implement operational opportunities for current and new processes.
• Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to support key production breakthroughs and establish relationships.

International travel will be required to visit contract manufacturing partner sites.

We are all different, yet we all use our unique contributions to serve patients. experienced professional we seek is a strong communicator and successful collaborator with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of scientific, engineering and/or related experience
• Associates degree and 8 years of scientific, engineering and/or related experience OR
• Bachelors degree and 4 years of scientific, engineering and/or related experience OR
• Masters degree and 2 years of scientific, engineering and/or related experience OR
• Doctorate degree

Preferred Qualifications:

• Masters or PhD in Science or Engineering
• 5+ years of experience in Process Characterization, Technical Transfer (to commercial drug product sites), and Process Validation of oral solid drug products.
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of wet granulation, roller compaction, blending, milling, drying, compression, encapsulation, and coating processes.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Pharmaceutical manufacturing experience in oral solid drug products.
• Project management skills including the ability to manage numerous projects and evaluate project resource requirements.
• Solid understanding of quality and regulatory systems, drug product manufacturing and process validation.
• Experience handling and building positive relationships with contract manufacturing organizations.
• Proven ability in providing leadership to multi-functional teams to advance sophisticated projects to completion.

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, well 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

for a career that defies imagination

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

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.