Post Doctoral Fellow

Career Category

Operations

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Post Doctoral Fellow

Let's do this. Let's change the world. In this vital role Amgen isseekinga highly motivated Process Development Postdoctoral Fellow to join the Drug Product Technologies organization. The Fellow will lead an innovative research project focused on enablinghighconcentration biologic drug products throughparticle engineeringandsuspensionbasedformulation and fill/finish approaches.

The Drug Product Technologiesgroupis responsible forphaseappropriate drugproduct formulation and fill/finish process development for large molecule modalities (e.g.monoclonal antibodies, bispecific T-cell engagers (BiTEs), antibody drug conjugates (ADC's) and fusion proteins).

• Design and execute studies to develop highconcentration protein formulations by evaluatingviscosityreducing excipients and formulation strategies to enhance product performance and delivery

• Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g.UF/DF,spray drying,mixing, stability)

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

• Apply solid-state(SEM, DSC, DVS) methods toestablishrelationships among formulation composition, particle structure, stability, and product performance

• Perform rheological characterization of highconcentration formulations and suspensions

• Develop and evaluate concentrated protein suspension formulations for parenteral delivery, including assessment of device compatibility

• 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 verifytechnical 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.

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

Basic Qualifications:

PhD at time of appointment

Preferred Qualifications:

• Familiarity with pharmaceutical/biotechnology process development

• Ability to learn new techniques, perform multiple tasks simultaneously, keepaccuraterecords, 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)

• Experience developing spraydried particles or microparticlescontainingproteins, peptides, biologics, or other complex pharmaceutical modalities.

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

• Experience developing concentrated protein suspension formulations for prefilled syringe applications, including syringe compatibility testing, break-loose force extrusion force, injectability, and dosedelivery performance

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

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

• Self-motivation,adaptability and a positive attitude

• Critical thinking, problemsolvingand independent research skills

• Good organizational skills with strong attention to detail

• Excellent communication (oral and written)

As we work to develop treatments that take care of others, we also…