Associate Scientist II/Sr. Associate Scientist

About the position

The Associate Scientist II, Formulation Development will design, prepare and characterize the different formulations for the drug product. Will conduct pre-formulation and formulation characterization studies to support drug product development. This involves performing lab activities, analyzing the data, planning studies, communicating and presenting lab results to cross-functional team members and clients as required.

Responsibilities

• Designs & develops formulations for monoclonal antibodies, antibody drug conjugates, bispecifics and fusion proteins from development programs for preclinical and clinical studies (liquid and lyophilized forms).
• Prepares and runs samples for the characterization of the stability samples using various techniques (TFF, IEX, SEC, Fluid Imaging, CE-SDS, pH, etc.).
• Monitors stability and incompatibility of formulations.
• Summarizes and presents characterization data on formulations in reports and presentations prepared and issued in a timely manner.
• Conducts troubleshooting of pre-formulation & formulation challenges and recommends potential solutions.
• Collaborates with members of the Formulation Development and/or Analytical Development groups on projects in discovery & clinical development.
• Evaluates new technologies and innovations to improve operational efficiency or expand department capabilities.
• Maintains appropriate experimental records in electronic laboratory notebooks.

Requirements

• BS or MS in Biological Sciences or related disciplines with 2+ years of relevant research and/or industry experience in Analytical development and Formulation development.
• In-depth understanding of protein chemistry and industry-standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, Fluid Imaging, compendial assays, etc.).
• Hands-on experience with planning and analyzing data through Design of Experiment (DOE).
• Ability to troubleshoot assay failure related to equipment or execution and identify root cause.
• Creative thinker that can identify better and more efficient methods to address issues and gaps.
• Demonstrate ability to work independently and on cross-functional teams.
• Strong attention to detail.
• Effective verbal and written communication skills.
• Enthusiastic learner.

Benefits

• Health benefits at a subsidized rate.
• Healthcare, Dental, and Vision insurance.
• Life Insurance and Disability Program: 100% covered by Bionova.
• Retirement Plan (401K) Up to 8% of Employer Match.
• Paid time off up to two weeks.
• 10 days of Holidays and 5 days of Sick Leave.