The incumbent will participate in the formulation and process development of biotherapeutics. This position will be responsible for performing analytical testing and characterization of candidate molecules by using various biophysical, biochemical and particulates characterization techniques as well as supporting laboratory operations and maintenance. This is a laboratory-based position performing formulation and process development activities specifically for biotherapeutic products from pre-clinical and Ph I clinical trials through late stage, license application and commercialization. Furthermore, this position will assist in data compilation, data presentations, report authoring, and department documentation support.
RESPONSIBILITIES:
The responsibilities of this position include, but are not limited to:
- Support the development of parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody drug conjugates, proteins, mRNA and vaccines.
- Perform rapid, comprehensive characterization of candidate molecules to determine the stability profile. This will be achieved by applying various biophysical, biochemical, particulates characterization techniques such as HPLC (SE-HPLC, IEX, HIC, RP-HPLC), Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), Spectroscopy techniques, light obscuration, microflow imaging and additional characterization techniques.
- Provide general laboratory support, including ordering/replacement of reagents and consumables, general maintenance of equipment, continuous improvement activities, and participating in periodic lab inspections.
- The incumbent must be able to interact effectively with a multidisciplinary team of scientists for formulation optimization and overall candidate progression.
- This position will be responsible for preparing data summary presentations, providing data verification support, compiling data, and using lab-based systems for data collection such as Empower and electronic laboratory notebooks.
- Effective communication skills are required for interactions with laboratory scientists, project managers and colleagues from numerous functions.