Director, Process Development - Attribute Sciences

Career Category

Process Development

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 Attribute Sciences. You will build and scale the capabilities, operating model, and cross-site partnerships needed to advance Attribute Science’s deliverables for Amgen products across the product lifecycle. You will ensure a high level of quality in the work performed. You will partner with key internal stakeholders to build this organization, define the required capabilities, and resource it with qualified personnel who have the education, experience, and training needed to perform the work in alignment with Amgen values.

As Director, Process Development - Attribute Sciences, you will report to the Executive Director, Process Development and:

Report dotted line to Attribute Sciences leadership, leading a team at AIN focused on advancing Attribute Sciences deliverables for all Amgen products

Build and lead an Attribute Sciences team at AIN with capabilities across method monitoring and lifecycle management, method transfer, regulatory and technical authoring, data analytics, and automation/digital tools

Work with functional partners within AIN as well as other Amgen sites and teams to define roles and responsibilities, hire and build new teams, and implement new processes

Establish the operating model, governance, and engagement framework for the AIN Attribute Sciences team in partnership with Attribute Sciences leadership and AIN site stakeholders

Create strong communication channels with existing Attribute Sciences teams across Amgen sites to establish and drive knowledge sharing, learning, networking, and effective global handoffs

Partner with cross-functional teams to establish and improve digital tools, data flows, and analytical ways of working as the voice of customer

Manage the Attribute Sciences team at AIN to ensure timely completion of goals and objectives with appropriate scientific rigor, quality, compliance, and customer focus

Set project timelines and priorities for key initiatives and team activities; translate business, technical, and regulatory needs into team capabilities, priorities, and execution plans

Lead and develop the team, providing staff member supervision, ongoing coaching, and structured capability development

Strategically plan, analyze, and manage resources, including budget, contractors, staff, and capacity

Act upon performance metrics, method health trends, and process issues; implement actions that drive continuous improvement and escalate material risks to management as needed

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 analytical sciences, process development, manufacturing, or biotechnology experience OR

Master’s degree and 15 years of analytical sciences, process development, manufacturing, or biotechnology experience OR

Bachelor’s degree and 20 years of analytical sciences, process development, manufacturing, or biotechnology 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 analytical development, attribute sciences, process development, quality control, or commercial analytical support experience in the biotechnology or pharmaceutical industry

Advanced degree in Analytical Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Pharmaceutical Sciences, or related discipline

Expertise in analytical method development, qualification/validation, transfer, troubleshooting, lifecycle management, and product-attribute control strategies for biologics and/or small molecules

Knowledge of cGMP regulations and expectations (FDA, EMA, Health Canada) and relevant analytical guidance, including ICH Q2 and ICH Q14 principles

Working knowledge of analytical technologies and data interpretation applicable to characterization, release, stability, comparability, and process monitoring

Experience applying automation, artificial intelligence, machine learning, or large language model-enabled tools in a compliant enterprise environment

Knowledge of statistics, data analytics tools and methods, including use of performance metrics and trend analysis to support analytical method health

Knowledge of project management tools and Agile methodologies

Strong leadership skills with the ability to build teams, establish new capabilities, and implement effective processes

Demonstrated ability to lead and coach cross-functional teams, consistently deliver on time, and produce high-quality results

Strong verbal and written communication, including the ability to communicate level of risk, urgency, or business impact effectively to senior and executive leadership

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.

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