US-MA, Scientist, Formulation Development 1602453-MZ
Provides theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area. Independently plans and executes most unit operation characterization and optimization experiments within expertise and develops an awareness of unit operations in other areas. Responsible for significant or sole technical leadership within project or complex study. Prepares technology transfer documentation and regulatory documents or coordinates with team members to ensure execution. Represents line functions on GCT teams as appropriate/necessary. Proactively identifies process or study issues/challenges and proposes potential resolutions.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience:
Knowledge and Skills:
LINE FUNCTION SPECIFIC QUALIFICATIONS
Protein formulation development experience preferred; Experience with analytical methods used for protein analysis such as HPLC, CE, spectroscopy, and sub-visible particle analysis; Knowledgeable about Design of Experiments and statistical principles for experimental design and data analysis; Exposure to the development of combination products and drug antibody conjugates preferred; Experience leading technology transfer to aseptic drug product manufacturers preferred
May require approximately 5-10% travel.
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