Drug Product Development and Operations (DPDO) is part of a highly experienced Chemistry, Manufacturing and Controls (CMC) organization responsible for developing and delivering robust and competitive biological drug products and manufacturing processes with stability, safety, and efficacy from discovery through commercialization. In the life cycle of product development, we leverage optimal DOE, rigorous scientific practice, and cutting-edge characterization tools to inform formulation and process selection.
Job Title: Scientist-Formulation Development
Location: West Chester, United States, Pennsylvania, 19380
Job Id: 50196
Your experience and qualifications
Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry, Chemical/Biomedical Engineering or other related discipline with a 2 years of experience – OR- Master’s degree with 5 years of experience -OR- Bachelor’s with 8 years of experience. (Fundamental knowledge and experience in biologic formulation and sterile product development.)
The opportunity
The DPDO team is looking for a strong candidate for the position of Scientist focusing on the development of protein-based therapeutics.
The successful candidate for this position will lead projects and studies, execute formulation development activities and analytical tests, organize the data and author related technical documents. The role will be expected to be a subject matter expert that supports formulation development and represents DPDO on a matrix project team.
How you’ll spend your day
- Design and develop patient-centric sterile products for biologics via the generation of experimental designs, execution of the study plans, and comprehensive data analysis
- Perform routine characterizations and analytical tests (e.g. chromatographic, electrophoretic, biophysical tests) for liquid and lyophilized biologic drug products.
- Support both early and late stage development activities including screening and developing robust drug product composition, developing scalable process with robustness, and defining primary packaging
- Document data following applicable lab procedures and current documentation practices; Maintain best practice of knowledge/data management
- Author protocols, reports, technical documents and other relevant CTDs for regulatory filings including IND/IMPD and marketing applications as needed.
- Collaborate with key stakeholders in matrix team to drive critical project milestones
- Coordinate with external contracting organizations to accomplish project goals as needed and serve as point of contact on the outsourced activities.
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