Company:

Our client is a clinical stage biopharmaceutical company focused on developing therapeutic antibodies.

Function:

Purification and Formulation Process Development and Manufacturing

Reporting Manager:

Director, Downstream Process Development

About the Opportunity:

We are seeking a highly motivated Senior Research Associate/Associate Scientist to become an integral member of the Downstream Process Development group. The Downstream Process Development group is responsible for critical drug development functions such as: development of robust downstream processes, technology transfer and scale-up to contract manufacturing facilities, and technical support and overseeing of manufacturing at contract manufacturing facilities. The scope of the position and requirements are described below.

Role and Responsibilities:

• Develop and scale-up robust multi-step purification processes
• Design and execute drug substance formulation studies
• Present experimental data in project and group meetings
• Author technical reports
• Implement new purification technologies to optimize and streamline processes
• Transfer and oversee purification process at CMO for GMP manufacturing
• Review executed batch records from CMO manufacturing
• Produce material for in-house development

Education, Experience and Qualification Requirements:

• Bachelors or Masters degree in Chemistry, Biochemistry or related scientific field.
• 4+ years of relevant industry experience for MS and 6+ years for BS level candidates.

Core Competencies, Knowledge and Skill Requirements:

• Experienced in protein purification techniques including column chromatography, standard membrane filtration and Ultrafiltration/Diafiltration
• Working knowledge of AKTA systems and Unicorn programming
• Ability to analyze and interpret complexed process data
• Work independently and proactively with minimal supervision
• Strong interpersonal skills and excellent oral and written communication skills
• Ability to travel and perform Person-in-Plant manufacturing oversight at a CMO is preferred
• Experience working with external manufacturing vendors and partners is preferred