Temp Process Development (Purification - Virus Clearance)

Process Development Associate-R46262

Position Description

We are seeking a Temp, Process Development Associate for a temporary position to work in the Purification Development group within Pre-Clinical Manufacturing and Process Development. The qualified individual will be primarily involved in the design and implementation of viral clearance studies to demonstrate virus safety of biotechnology products throughout the product development cycle from Phase I clinical trials through commercial licensure. The successful candidate is intellectually curious and passionate about science, an effective collaborator across multiple functions within and outside department, and able to perform key responsibilities in a fast-paced, team environment.

Roles Responsibilities

• Supports multiple viral clearance projects by performing scale-down models for viral inactivation, chromatography, and membrane filtration unit operations
• Travels to external laboratories (20 ? 25%) to execute viral clearance studies in accordance with GLP
• Collaborates with cross-functional groups to coordinate study logistics
• Summarizes studies and results in electronic laboratory notebooks or technical reports
• Presents work at team or group meetings
• Reviews protocols, reports, risk assessments and other technical documents
• Maintains and troubleshoots equipment and instrumental/experimental problems
• Supports developing state of the art technologies influencing viral clearance or protein purification
• Contributes to continuous improvement efforts within functional area
  
  

Skills

• Enjoy a fast paced pilot scale laboratory setting where sound science and team work are the priorities.
• Contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.
• Anticipate and recognize potential problems with laboratory supplies / equipment and act to prevent and tackle problems.
• Working knowledge of various protein purification principles preferred.
• Working skillset in laboratory techniques, including but not limited to pipetting, solution preparation, pH titration, and aseptic technique a plus.
• Relevant experience or familiarity with one or more of the following: statistical analysis, chromatography, membrane filtration, AKTA systems, JMP, Unicorn software, cGMP, cGLP, cGDP, process validation and regulatory requirements preferred.
• Coding experience using RStudio, Python, Matlab, or similar platforms is a plus; Capable of occasional travel for work.
  
  

Education & Experience

• Bachelor?s and/or Master?s degree in either Chemical Engineering, Biochemical Engineering, Biochemistry, Virology, or related fields and 0 - 5 years? experience in the biotechnology or pharmaceutical industry.