Scientist I, Biologics Drug Product Development

Role Summary

Support formulation and process development of protein biologics from early development through commercialization, with a focus on highly potent compounds for therapeutic and aesthetic use. Design, execute, and report laboratory experiments to advance the development of stable and effective biologic formulations. Collaborate across multidisciplinary teams to solve technical challenges in formulation and process optimization, enabling clinical and commercial progression of therapeutic biologics.

Responsibilities

• Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms.
• Manufacture drug product formulation batches for evaluating formulation stability and/or for animal studies.
• Conduct clinical in-use studies to guide dose solution administration.
• Perform analytical testing and characterization of biologic samples, assessing critical quality attributes to support formulation and process decisions.
• Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments.
• Thoroughly document experimental procedures, results, and interpretations in laboratory notebooks and reports, ensuring compliance with company and regulatory standards.
• Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, and scientific presentations.
• Participate in the evaluation, implementation, and ongoing improvement of new and existing technologies, techniques, and equipment to continuously enhance formulation and process development.

Qualifications

• BS with a minimum of 5 years or MS with a minimum of 2 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry
• Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Candidates must be highly organized and detail oriented.
• Hands-on laboratory experience in biologics formulation development, drug delivery, drug product manufacturing processes, lyophilization or analytical functions is preferred.
• Prior hands-on experience working with highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment is strongly desired.
• Strong organizational and documentation skills; ability to maintain accurate experimental records and reports.
• Effective verbal and written communication skills with the ability to work collaboratively in cross-functional teams.