Associate Scientist
BioSpace
About the Role
This role supports drug product development activities from candidate selection and pre-clinical development through clinical development and commercialization.
Key Responsibilities
- Execute laboratory experiments including formulation development, stability and compatibility testing, new technology assessment, and process development.
- Generate data to support formulation and drug product development.
- Analyze and interpret data using statistics software (JMP).
- Draft experimental protocols for routine experiments and follow established procedures.
- Develop thorough knowledge of core assays.
- Participate in routine lab and instrument maintenance.
- Maintain a high standard of data quality and integrity by adhering to ALCOA+ principles.
- Use data management systems such as ELN, SDMS, LIMS, and EDMS.
- Contribute to technical documents including Protocols, Analytical Procedures, Technical Reports, Technology Transfers, Risk Assessments, and Regulatory Submissions.
- Generate and organize data figures and tables.
- Communicate critical data to supervisor and team.
Requirements & Tech Stack
- Ability to take direction and guidance for data-driven decision making, priority setting, and technical problem-solving.
- Experience with HPLC/UPLC (Preferred).
Qualifications
- BS or MS in a scientific or Engineering discipline.
- 0-3 years relevant experience.
- Experience working across a variety of drug modalities (e.g., mAb, ADC, siRNA, AAV, LNP).
- Experience with liquid and lyophilized drug product and novel drug delivery technologies.