Process Development Senior Scientist, Late-Stage Drug Product Development

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 Senior Scientist, Late-Stage Drug Product Development

Lets do this. Lets change the world. In this vital role you will work as part of a group that is responsible for late stage drug product formulation and process development for biologics modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins).

• Design, plan, and execute laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge.
• Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development and process characterization.
• Author and review guideline documents, technical protocols, and reports.
• Author and review regulatory sections in support of IND and marketing application submissions.
• Lead multiple activities in parallel to drive project plans to completion, meeting project timelines and landmarks.
• Perform data analysis using sophisticated statistical/analytical techniques with a proficiency in statistical analysis software.
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs.
• Effectively and consistently connect with management, multi-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs.
• Ability to travel domestically up to 10% of the time.

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

Basic Qualifications:

• Bachelors degree and 5 years of Scientific experience; Or
• Masters degree and 3 years of Scientific experience; Or
• Doctorate degree PhD OR PharmD OR MD

Preferred Qualifications:

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area.
• 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field.
• Knowledge of/experience with formulation and commercial process development for liquid and lyophilized drug products.
• Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.
• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality.
• Experience with coding/scripting for automated data analysis and modeling.
• Experience with data visualization tools or packages, such as Tableau or Spotfire.
• Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiment.
• Critical thinking, problem solving and independent research skills.
• Strong project management skills, including the ability to lead ones project resources.
• Good organizational skills with strong attention to detail.
• Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally.

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

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.

Salary Range