Process Engineering Intern (25300-T-680-PS)

WHAT YOU’LL DO

• Plan, execute, analyze, and report on experiments and analytic assays to support the development, process characterization, and process validation of drug product GMP process to manufacture, characterize, and release T cell therapy products
• Execute in-process, product, and in-use T cell stability studies using various candidate drug product container configurations to enable various clinical dose levels
• Execute cryopreservation characterization studies to optimize thermal load distribution and ensure product stability during crucial cryopreservation unit operations
• Evaluate secondary and tertiary Drug Product container configurations to develop and optimize end-to-end drug product transportation and delivery strategy
• Collaborate closely with other functions to enable effective and successful project execution
• Actively engage in cross-functional collaboration with peers
• Organize, communicate, and present data to key stakeholders
• Assist cross-functional activities including hand-offs to various teams, compiling data, and presenting at technical meetings


Opportunities for Candidate Learning
• Opportunity to gain experience working in an industry BSL 2 lab environment with specialized cell therapy processing equipment 
• Opportunity to learn about and execute flow cytometry assays to characterize cell product quality prior to and after cryopreservation
• Opportunity to gain familiarity with the drug product development lifecycle and clinical trial design and execution from a trial sponsor perspective
• Opportunity to learn about GMP process design principles and use of engineering and process controls in order to maintain drug product quality
• Opportunity to learn about and provide input on logistical considerations for shipping drug product to trial centers while introducing sufficient controls to ensure product quality 

WHO YOU ARE

• Current 3rd or 4th year undergraduate student enrolled in a Bachelors degree program studying Biology, Biochemistry and Molecular Biology, Immunology, or similarly relevant degree program
• Experience working in a biological laboratory setting with basic lab techniques (e.g. use of PPE, pipetting, centrifuge balancing, lab notebook documentation, aseptic technique) is required
• Ability to quickly adapt and learn new skills for changing research priorities
• Flexible mind with the ability to think outside the box, creative approach to problem-solving
• Demonstrated ability to work well in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines
• Willingness to accept other responsibilities outside of initial job description
Preferred qualifications 
• Experience with human immune cell isolation, T cell expansion, and mammalian cell culture techniques is desirable
• Knowledge of cell therapy and/or gene therapy is desirable
• Experience with data visualization software (e.g. JMP, Prism, Tableau) is a plus
• Familiarity with/knowledge of biological assays (PCR, Flow Cytometry, Cytokine ELISA) is a plus