Director Process Development

Director Process Development

Join Amgen's mission of serving patients. Our shared missionto serve patients living with serious illnessesdrives 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.

The Director of Process Development will serve as the Similarity Lead, driving cross-functional teams in the development of multiple biosimilar products from pre-clinical through commercial stages. This role is responsible for developing and executing strategies for analytical and nonclinical similarity assessments, supporting regulatory approval and commercial success for Amgen biosimilar products. The Director will collaborate with internal and external stakeholders, providing scientific, business, and tactical leadership.

Key Responsibilities :

• Lead the development and execution of analytical and nonclinical similarity assessment strategies.
• Oversee cross-functional collaboration with various teams.
• Guide process development to achieve similarity.
• Provide scientific leadership in the characterization of biochemical, biophysical, and functional properties.
• Design and implement in vitro pharmacology study plans.
• Advise on statistical analysis and graphical presentation approaches.
• Author and review analytical similarity sections for regulatory submissions.
• Lead responses to scientific questions from global regulatory agencies.
• Collaborate with internal and external partners to support analytical development.
• Contribute to biosimilar publication plans and external scientific communications.

What we expect of you :

The professional we seek is a go-getter with these qualifications :

Basic Qualifications :

Doctorate degree and 4 years of pharmaceutical experience OR Master's degree and 8 years of pharmaceutical experience OR Bachelor's degree and 10 years of pharmaceutical experience. In addition to meeting at least one of the above requirements, you must have at least 4 years of experience directly managing people and / or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Preferred Qualifications :

Additional Information :

This position is critical to Amgen's biosimilar strategy and requires a leader who is comfortable working in a dynamic, collaborative environment. The successful candidate will be expected to interface with broad cross-disciplinary business functions and external partners, contribute to strategic decision-making for Amgen biosimilar business unit, and support the company's mission to deliver high-quality biosimilar products.

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.

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 :

Apply now and make a lasting impact with the Amgen team.

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.

Sponsorship for this role is not guaranteed.

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.