Process Development Scientist - Global Method Implementation Team (GMIT)

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.

Process Development Scientist - Global Method Implementation Team (GMIT)

What you will do

Let's do this! Let's change the world!

Amgen is seeking a Scientist within our Process Development Commercial Attribute Sciences (CAS) team to join Amgen's Global Method Implementation Team (GMIT).

GMIT is a centralized organization which owns and manages method transfer and validation strategy and projects across all late-stage programs in the Amgen portfolio. GMIT is an industry-leading entity that drives innovative strategy and robust technical method implementation both internally and with external partners, enabling advancement of programs from clinical through commercial as well as post-launch.

The Scientist will join a highly talented global group of scientists who lead complex method implementation projects to advance Amgen's multimodality portfolio and lifecycle management projects. As part of this opportunity, you will maintain strong cross-functional partnerships, contribute to method validation and transfer strategies, produce compliant method implementation documentation, and partner with our GMIT, Attribute Sciences (AS) Team Leads and Subject Matter Experts (ASTLs and SMEs), and Quality leads to successfully meet program timelines. The scope of work and responsibility includes support of GMIT method implementation projects, continuous improvement of the method implementation business process and compliance to evolving regulatory expectations and developing a deep understanding of method implementation processes.

GMIT owns method implementation projects across a wide range of analytical platforms including: Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, and General (compendia based) for biologics, synthetics, and raw material release, in-process and stability testing. This position works closely with representatives from key partner functions within Process Development, Manufacturing, and Quality in highly matrixed environments. There is some flexibility in the location of the successful candidate and the role may include a small amount of travel (estimated at 10% or less).

Key responsibilities:

• Work under minimal supervision to support complex method implementation projects and enable successful global regulatory filings with minimal direction

• Proactively support technical strategies, convey information and communicate on technical challenges to project teams and GMIT project leads

• Work with GMIT project leads to support CMC regulatory documents and documentation in support of Amgen's regulatory filings, as well as regulatory and partner inspections

• Motivate, develop, and promote team collaboration

• Innovate and drive efficiency

• Achieve work in a matrix organization with others who you may or may not report directly to

• Track and communicate project and task performance

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Bachelor's degree and 4 years of relevant Operations or Scientific experience OR

• Master's degree and 2 years of relevant Operations or Scientific experience OR

• Doctorate degree

Preferred Qualifications:

• Degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, Biochemical or Chemical Engineering, or other Biological Science

• Exceptional communication, collaboration, and project management skills

• Working knowledge of multi-modality (biologic, synthetic, etc) analytical methods/technologies including but not limited to: Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, and General/Compendial

• Understanding and hands-on experience with method validation and method transfer for clinical and commercial programs per ICH Q2 including direct industry experience

• Working knowledge of product quality attributes and control strategies

• Working knowledge of regulatory expectations related to analytical control and method implementation strategies

• Strong ability to organize, analyze, and interpret data including statistical methods

• Working knowledge in applicable US and worldwide regulatory requirements for biologics and synthetic pharmaceutical products in a GMP environment

• Growth mindset

• Experience in development and/or support of biomanufacturing processes

• Knowledge of CMC clinical and commercialization process development

• Success and experience with functional or cross-functional project teams

• Track record of innovation and implementation of Continuous Improvement ideas

• Basic knowledge of regulatory filings and interaction with regulatory agencies

• Emotional intelligence

• Agility and one-team mindset

What you can expect from 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:

• 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

Apply now

for a career that defies imagination

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

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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.