Scientist/Senior Scientist of Biologics Analytical Development – Bioassay

Description:

We are looking for Scientist/Sr. Scientist who will be part in the development and management of bioassays for characterization and release of biological product candidates. The successful candidate will independently develop and qualify biological methods (potency assays and other relevant bioassays) to both characterize and release of biologics.

Job Requirements:

• PhD in Chemistry / Biochemistry or in related field with 3 to 8+ years (or Masters/Bachelors Degree in relevant field with 5 to 12+ years) of relevant experience in bioassay method development and biological characterization of biologics supporting CMC sections for IND, IMPD/CTA, and BLA submissions.
• 2+ years of demonstrated team leadership of Research Associates/Scientist as well as project management.
• Essential hands-on experience and in-depth knowledge of state-of-the-art instrumentation and modern bioassay related analytical techniques (e.g., ligand binding assays, antigen binding assays, mechanism of action based functional assays, Fc receptor binding assays, ADCC, CDC, ADCP, apoptosis, trogocytosis, etc.)
• Extensive experience with biological characterization of biologics (including process & product impurities, degradation product characterization), method development/qualification validation, and tech transfer supporting early and later stage development for proteins/peptides, monoclonal antibodies, protein conjugates (e.g., pegylation, ect), antibody drug conjugates, vaccines, etc.
• Clear understanding of formulation development and stability studies as well as upstream/downstream processing is desired.
• Familiarity with cGMP compliance and Quality/Regulatory Affairs, including a clear understanding of phase appropriate CMC regulatory requirements is preferred.
• Demonstrated ability to set clear and measurable goals for staff and prioritize tasks and resources to superior work quality and efficiency.
• Excellent presentation, oral and written communication skills, be able to communicate effectively to senior management, cross functional teams, collaborators/partners.