About the position
We are seeking an energetic and highly motivated analytical research associate/senior associate/associate scientist with experience in protein formulations to join the Analytical and Formulation Development group. Standard protein/antibodies analytical skills are required for this position. Protein/antibodies formulation experience is a plus. Other than executing formulation studies, this position also provides the opportunities of leading formulation developments of various novel antibody-based molecules.
Essential Duties and Responsibilities
The major responsibilities of this position include the development of novel antibodies formulations. The successful candidate will develop and use stability indicating analytical and characterization methods, plan and execute pre-formulation studies and formulation development, analyze and interpret high quality data, and generate related reports for team meetings in a timely and efficient manner. The candidate will also need to generate SOP and related GMP documents to support successful implementation of process technology in clinical/commercial manufacturing operations. This position will also provide the opportunities of developing and conducting analytical methods to support upstream and downstream production process development.
- A BS or MS in Chemistry, Biochemistry or related discipline with 2+ years of industrial analytical experience
- Knowledgeable in protein sciences.
- Hands on experience in analytical and characterization methods including UPLC/HPLC methods (SEC, CEX, HIC), CE-SDS, cIEF, osmolality, viscosity, solubility, DLS/SLS, and other related biophysical techniques.
- Experience in liquid and frozen formulation development of antibody or non-antibody proteins is a plus.
- Experience with ADC characterization and formulation development is a plus.
- Proficient in Microsoft Word, Excel, and Power Point.
- Experience in writing Standard Operating Procedures (SOP) and relevant cGMP documents.
- Flexibility, excellent organizational skills and strong scientific problem-solving skills are required to enable successful execution of critical studies against tight deadlines.
- Excellent communication skills. Strong collaboration capability to work with other group members and departments to meet project timelines in a fast-paced team environment.