Director, Process Development- Drug Product

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.

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead a diverse team within our Process Development organization, maintaining accountability for its daily operations with a focus on Drug Product Technologies (DPT). You will build a new team, creating the capabilities, operating model, and cross-site partnerships needed to advance drug product deliverables for Amgen products. You will ensure a high level of quality in the work performed. You will partner with key internal stakeholders to build this new organization, define the required capabilities, and resource it with a team of qualified personnel who have the education, experience, and training needed to perform the work in alignment with Amgen values.

As Director, Process Development, you will report to the Executive Director, Process Development and Report dotted line to DPT leadership, leading a team at AIN that is focused on advancing drug product capabilities and deliverables

• Build and lead the Drug Product Technologies organization at AIN, establishing a high-performing team that expands global DPT capabilities and supports delivery across Amgen’s product portfolio.
• Establish AIN as an integrated extension of the global DPT organization by defining roles, responsibilities, operating model, governance, and engagement frameworks in partnership with DPT leadership, AIN stakeholders, and global site teams.
• Develop and scale team capabilities across technical documentation, regulatory authoring and support, data analytics, AI-enabled tools, automation, in-silico modeling, and process monitoring.
• Champion digital transformation across DPT workflows by translating scientific, business, and regulatory needs into requirements and partnering with Technology, Data/AI, and functional teams to develop, deploy, and continuously improve digital capabilities.
• Set strategic priorities, project timelines, and execution plans for key initiatives, ensuring timely delivery of goals and alignment with portfolio and organizational objectives.
• Recruit, onboard, coach, and develop talent; build future leaders; manage performance; and foster an inclusive culture of accountability, collaboration, and continuous learning.
• Plan and manage resources, including budget, contractors, and staff, to ensure effective delivery of team priorities and sustained organizational performance.
• Use performance metrics, process insights, and issue trends to drive continuous improvement, resolve barriers, and escalate risks as appropriate.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Doctorate degree and 8 years of drug product biotech experience OR

Master’s degree and 15 years of drug product biotech experience OR

Bachelor’s degree and 20 years of drug product biotech experience AND

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

Preferred Qualifications:

• 14+ years of drug product process development or manufacturing experience in biotech or pharmaceutical industry

• Advanced Degree in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline

• Knowledge of cGMP regulations (FDA, EMEA, Health Canada)
• Working knowledge of applicable drug product manufacturing/ testing processes (process development, process validation, commercial manufacturing)

• Experience applying automation, artificial intelligence, machine learning, or large language model-enabled tools in a compliant environment.
• Experience with regulatory filings

• Knowledge of statistics, data analytics tools and methods

• Knowledge of project management tools and Agile methodologies

• Strong leadership skills with the ability to build new teams and implement new processes

• Demonstrated ability leading and coaching cross-functional teams, consistently deliver on-time, and with high-quality results

• Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership, including communicating level of risk, urgency, or impact to the business

• Ability to operate in an international matrix or team environment with site, functional, and executive leadership

• Ability to flex working hours to maximize interactions with global teams.

What you can expect of 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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now for a career that defies imagination

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

careers.amgen.com

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.