Junior Application Scientist
3 weeks ago
Position Summary
Product Development Science & Technology (PDS&T) is seeking a highly motivated Scientist to support parenteral drug product process development, including formulation development, commercial site scale-up, and technology transfer activities. The Scientist will independently design, execute, and analyze laboratory studies aimed at developing robust manufacturing processes for clinical and commercial biologic drug products—including antibody drug conjugates (ADCs) and other injectable modalities.
This individual will be an integral member of cross-functional Product Development and CMC teams, contributing experimental insights, technical recommendations, and high-quality documentation to advance pipeline programs from early development through commercialization.
Key Responsibilities
Laboratory & Experimental Work
Independently design, plan, and execute experiments to develop, optimize, and scale parenteral drug product manufacturing processes (e.g., mixing, filtration, filling, lyophilization).
Conduct formulation robustness and stability studies evaluating the impact of pH, ionic strength, temperature, light, moisture, agitation, freeze–thaw, and other process-related stresses on biologic products.
Perform biomapping, filtration studies, and other analytical/engineering-focused investigations to support process understanding and manufacturability.
Execute protocols accurately, understand study objectives, order materials and consumables, and proactively communicate experimental needs.
Support commercial stability studies, including sample management, testing coordination, and data interpretation.
Process Development & Tech Transfer
Contribute to process development strategies for injectable biologics, including ADCs, ensuring robust scalability for clinical and commercial manufacturing.
Collaborate with senior scientists to design and refine experimental studies that advance drug product and process understanding.
Support scale-up and technology transfer activities with internal manufacturing groups or external commercial sites.
Help develop and refine compound processing approaches, including process parameters, controls, and risk assessments.
Data Analysis & Communication
Generate high-quality, precise, reproducible data and interpret results from multistage experiments.
Identify deviations or unexpected trends, troubleshoot root causes, and propose follow-up studies.
Prepare clear scientific documentation, including protocols, development reports, technical summaries, and regulatory-supporting documentation.
Communicate experimental findings effectively within cross-functional teams.
Qualifications
Education (Flexible):
BS in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related field with 7+ years relevant experience
MS with 3+ years experience
PhD with 0+ years experience
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