Process Development Associate at Amgen

Join Amgens Mission of Serving Patients

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.

Associate, Process Development - Drug Product Technologies

What you will do

Lets do this! Lets change the world!

The Drug Product Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug product manufacturing processes for all programs across the Amgen portfolio.

Amgen is currently seeking a Process Development Associate for our Drug Product Technologies Group. This group is responsible for phase appropriate drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), antibody drug conjugates (ADCs) and fusion proteins). The Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgens drug product commercialization and lifecycle management.

Responsibilities include:

• Participate in the execution of development studies by applying basic science/engineering skills and prior knowledge

• Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, filtration, freeze-thaw, stability)

• Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content)

• Build a wide range of data and analytics solutions, from available commercial dashboarding tools such as TIBCO Spotfire, MS Smartsheet

• Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)

• Author/review/data verify technical protocols and reports.

• Participate in team meetings by sharing study results and technical challenges.

• Adapt to flexible working hours to accommodate project needs and team collaboration.

• Navigate and thrive in an environment with ambiguity, demonstrating adaptability and problem-solving skills.

• Work effectively across different time zones and be respectful of diverse cultures.

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:

• Bachelors degree OR

• Associates degree and 2 years of manufacturing or operations experience OR

• High school diploma / GED and 4 years of manufacturing or operations experience

Preferred Qualifications:

• Bachelors degree in chemical engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related field

• Familiarity with pharmaceutical/biotechnology process development

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies

• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)

• Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality

• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)

• Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)

• Self-motivation, adaptability and a positive attitude

• Critical thinking, problem solving and independent research skills

• Good organizational skills with strong attention to detail

• Excellent communication (oral and written)

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, 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

Apply now

for a career that defies imagination

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

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Application deadline

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.