Postdoctoral Fellow, High-Concentration Biologic Formulations

BioSpace; Cambridge (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen is seeking a Process Development Postdoctoral Fellow to join the Drug Product Technologies organization. The role focuses on enabling high-concentration biologic drug products through particle engineering and suspension-based formulation and fill/finish approaches.

The Fellow will design studies, perform analytical evaluations, and build data analytics solutions to support formulation development for large molecule modalities such as mAbs, BiTEs, ADCs, and fusion proteins.

Qualifications

• PhD at time of appointment.
• 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 (e.g. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with analytical techniques (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 (SAS, JMP or Minitab).
• Experience with programming (Python, R, MATLAB), database languages (SQL), data analytics, data modeling as well as data visualization tools (Tableau, Spotfire, D3js).
• Self-motivation, adaptability and a positive attitude.
• Critical thinking, problemsolving and independent research skills.
• Good organizational skills with strong attention to detail.
• Excellent communication (oral and written).

Responsibilities

• 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 (UF/DF, spray drying, mixing, stability).
• Evaluate product and process performance through analytical testing (SEC, CEX, HIAC, MFI).
• Apply solid-state 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 Tableau, Spotfire, D3js.
• 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.

Skills

Python

R

MATLAB

SAS

JMP

Tableau

Spotfire

D3js

Data analytics

Problem solving

Communication

Education

PhD in a relevant field

Tools

SAS

JMP

Minitab

Python

R

MATLAB

Tableau

Spotfire

D3js

Job description

Amgen is seeking a Process Development Postdoctoral Fellow to join the Drug Product Technologies organization. The role focuses on enabling high-concentration biologic drug products through particle engineering and suspension-based formulation and fill/finish approaches.

The Fellow will design studies, perform analytical evaluations, and build data analytics solutions to support formulation development for large molecule modalities such as mAbs, BiTEs, ADCs, and fusion proteins.