If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between. 

Our summer intern program, which will run from May 27th – Aug 8th, allows students to gain real world work experience in a high energy, collaborative work culture.   

In this role, you will develop an understanding of commercial regulatory requirements to support the annual regulatory submission to the FDA. This includes conducting gap assessments for completed stability studies and preparing graphs to illustrate trending data in the annual submission. This role will gain insight into analytical oversight as a sponsor for vendor management collaborating remotely with our third-party manufacturers. In addition, you will contribute to organizing data to facilitate analytical oversight, align third-party review processes, and support regulatory readiness.

• Support FDA data readiness and organization of XPOVIO® products and annual regulatory submission, including gap assessments for completed studies
• Manage and organize analytical-related documents such as raw data, Certificate of Analysis (COAs), and reports
• Interface with third-party vendors to align analytical programs that support manufacturing and stability
• Collaborate with Analytical and GMP Quality team members to assist in KPTI stability programs review process
• Assist in site evaluations to support ongoing Failure Modes and Effects Analysis (FMEA) initiatives aimed at reducing data review time within the Analytical Team
• Participate in weekly telecons and cross-functional team meetings with external manufacturing sites and internal program teams

• Currently enrolled in a full-time chemistry or pharmaceutical sciences degree program with some pharmaceutical testing experience
• Strong communication and time management skills capable of working independently and cross-functionally in a remote work environment
• Strong organization skills with the ability to handle multiple projects simultaneously and effectively
• Proficiency with Microsoft Office including Word, Excel, PowerPoint, Teams
• Analytical or quality control experience in small or large molecules or oral drug products a plus for exposure to different types of data
• Familiar with a variety of analytical testing such as HPLC, GC, Dissolution, FTIR, UV/Vis, Karl Fisher titration, etc.
• Familiar with data analytics and trending including excel for graphing and hyperlinking source documents
• Interest in understanding FDA regulatory commitments in commercial programs
• Familiar with cGMP, USP, FDA, and ICH requirements a plus
• You have a strong interest in life sciences and are passionate about giving patients with cancer a chance to enjoy more of life’s precious moments.  
• You feel a strong connection with our ICARE values (Innovation, Courage, Alignment & Accountability, Resilience, and Energy) 
• You demonstrate enthusiasm for learning and a commitment to career development

At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!