Description

You will develop and characterize formulations and processes for biologic drug products in pivotal and commercial stages.

Responsibilities

• Perform protein formulation and stability experiments for liquid and lyophilized dosage forms using HPLC, capillary electrophoresis, and spectroscopy.
• Execute scale-down and scale-up activities for biologic drug product processes, including buffer preparation and UF/DF.
• Author protocols, technical summary reports, memos, and technology transfer documentation.
• Review Master Batch Records for accuracy and analyze process data to support fill/finish manufacturing operations.
• Support technology transfers to clinical and commercial manufacturing sites through study execution and technical support.

Required Skills

• 5+ years of experience with a BS degree or 3+ years with an MS degree in Pharmaceutical Sciences, Biology, Biochemistry, or Biochemical Engineering.
• Direct experience working with biologic molecules such as proteins or mAbs.
• Hands-on expertise in protein formulation and stability testing for various configurations like vials and syringes.
• Proficiency in biochemical and biophysical analytical techniques, including HPLC and capillary electrophoresis.
• Experience with analytical data analysis and compendiability testing (osmolarity, protein concentration, pH).
• Strong technical communication skills for presenting project goals and results in written and verbal formats.
• Foundational understanding of formulation and drug product process development for antibodies, fusion proteins, or vaccines.

Preferred Skills

• Experience with Antibody Drug Conjugates (ADC).
• Knowledge of biologic drug product processes such as freeze-thaw, filtration, mixing, filling, and lyophilization.

Key Skills

Education

Any Gradute