Process Development Scientist, Protein Formulations & Stability

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen is seeking a Process Development Associate Scientist in Thousand Oaks, CA, to contribute to diverse early-stage portfolio projects across modalities, focusing on formulation development and stability characterization of large molecule drug candidates.

The role requires hands-on experience in drug product formulation and process development, providing scientific expertise to advance the pre-pivotal portfolio.

Qualifications

• Master's degree in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, Biophysics, or related field with a minimum of 3+ years of industrial experience in pharmaceutical/biotechnology or related field.
• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality.
• Experience in antibody characterization, stability, and development of parenteral controlled release delivery systems.
• Sophisticated understanding of predictive methods, protein stability and solubility.
• Preferred experience in biophysical analysis (Light scattering, DSF, AUC, FFF), mass spectrometry (peptide mapping), high throughput screening and data analytics.
• Preferred understanding of drug delivery and devices related to product development.
• Proficiency in statistical software (such as JMP), experience with data visualization tools or packages (Tableau or Spotfire).
• Strong independent problem‑solving skills.
• Ability to learn and act on dynamic information at a rapid pace, hard‑working and collaborative attitude.
• Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results for a fast pace and cross functional environment.

Responsibilities

• Routinely plan, design, complete, and document stability studies related to FIH formulation development and fill/finish process development, in support of product commercialization.
• Responsible for design and execution of in use compatibility studies for clinical to mimic clinical dose preparation and administration
• Conduct stability studies, to support liquid and lyophilized formulations.
• Complete development of multi-modality protein drug formulations and analytical characterization of proteins via HPLC/UPLC/2-D HPLC methods, subvisible particle analysis, viscosity characterization, mass spectrometry, capillary electrophoresis, biophysical analysis.
• Active participation and representation of drug product process development group in cross‑functional project teams across organization
• Continuous adherence to compliance and quality and compliance while meeting organizations goals and priorities
• Author/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
• Meticulous data collection, documentation using electronic data capture systems
• Ability to work in a matrixed team and present data cross functionally

Skills

Biopharma formulation

Stability studies

Data analysis

HPLC/UPLC

Protein characterization

Cross-functional teamwork

Communication skills

Education

Master's in Pharmaceutics/ Biotechnology/ Biochemistry

Bachelor's + 2 years scientific experience

Associate + 4 years scientific experience

High school diploma + 6 years scientific experience

Tools

HPLC/UPLC

Mass spectrometry

DSF

AUC

Biophysical analysis

JMP

Tableau/Spotfire

Job description

Amgen is seeking a Process Development Associate Scientist in Thousand Oaks, CA, to contribute to diverse early-stage portfolio projects across modalities, focusing on formulation development and stability characterization of large molecule drug candidates.

The role requires hands-on experience in drug product formulation and process development, providing scientific expertise to advance the pre-pivotal portfolio.