Process Development Associate
BioSpace
About the Role
Amgen is seeking a Process Development Associate to join their mission of serving patients. The role focuses on developing clinical and commercial products for solid oral dosage forms.
Key Responsibilities
- Provide hands-on formulation and process expertise for solid oral dosage forms (small molecule focus).
- Design and develop specialized digital tools and applications for the synthetic drug products team to streamline experimental workflows.
- Enable accurate and efficient calculation of critical parameters to support data-driven decision making in process development.
- Collaborate across departments (analytical, R&D, manufacturing) to align project goals, resolve technical challenges, and ensure timely progress.
- Act as a liaison to integrate diverse expertise and maintain momentum on high-priority initiatives.
- Contribute to drafting scientific review papers and technical guideline documents through in-depth data analysis and experimental work.
- Support scientific content development via literature research, experimental validation, and cross-functional collaboration.
- Interface within Drug Product Technologies and external functions as a team member.
- Contribute to experimentation design and execution, assisting in data analysis and interpretation.
- Showcase understanding of organic and physical chemistry, material sciences, and statistics.
- Organize and communicate information within the team to drive optimal formulation and processes for drug development.
Requirements & Tech Stack
- Masters degree (or foreign equivalent) in Bioengineering, Pharmaceutical Sciences, Chemical or Pharmaceutical Engineering, Chemistry, Life Sciences, or a related field.
- Completion of a university-level course, research project, internship, thesis, or one year of experience.
- Understanding of unit operations and formulation principles for oral solid dosage forms and related pharmaceutical processes.
- Proficiency in programming languages such as Python, R, and MATLAB.
- Experience in developing and enhancing AI-driven digital tools and user interfaces.
- Experience with GMP-compliant manufacturing operations under established SOPs.
- Experience introducing and integrating new digital modalities and visualization tools like Figma, Power BI.
- Knowledge of image and statistical analysis tools including IMARIS, GraphPad Prism, and Excel.
- Experience in market research, data analysis, statistical design, and literature review.
- Experience with ELN systems.
Qualifications
- Ability to demonstrate understanding of organic and physical chemistry, material sciences, and statistics.
Full-Time Position.
Annual Salary Range (U.S.): $74,503.00 - $100,799.00.
Benefits include stock, retirement, medical, life, and disability insurance, and eligibility for an annual bonus.