Post Doctoral Fellow

Career Category

Operations

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. 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

What you will do

Let’s do this. Let’s change the world. In this vital role Amgen is seeking a highly motivated Process Development Postdoctoral Fellow to join the Drug Product Technologies organization. The Fellow will lead an innovative research project focused on enabling high concentration biologic drug products through particle engineering and suspension based formulation and fill/finish approaches. The Drug Product Technologies 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 (ADC’s) and fusion proteins).

• Design and execute studies to develop high concentration protein formulations by evaluating viscosity reducing 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 to establish relationships among formulation composition, particle structure, stability, and product performance

• Perform rheological characterization of high concentration 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 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 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, 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)

• Experience developing spray dried particles or microparticles containing proteins, 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 dose delivery 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 modeling 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 from us

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