Company:
Our client is a clinical stage biopharmaceutical company focused on developing therapeutic antibodies.
Function:
Purification and Formulation Process Development and Manufacturing
Level:
Senior Research Associate/Associate Scientist
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
