Summer Intern - GMP Quality

Role Overview & Key Functions:

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.   

You will positively impact patients’ lives by: Assisting with all Quality Unit (QU) efforts and activities, including Quality Assurance (QA) and Quality Control (QC) within the organization and the Contract Service Providers, including the development and implementation of the programs. You will be helping GMP Quality with management of Product Quality Complaints and Annual Product Quality Reviews.

Participate in following activities to support GMP (Good Manufacturing Practice) Quality Operations:

• Assist GMP Quality Manager in data collection and report generation for Annual Product Quality Review (APQR) for Karyopharm’s commercial product. This project will require creation of excel lists, statistical analysis, and technical writing. This will give an individual overview of drug manufacturing and testing process along with affiliated regulations and guidelines.
• Assist in management of minor product quality complaints investigations in Veeva Vault. This project will require individuals to learn and execute documentation for complaint investigations.
• Develop Smartsheets and trackers for GMP Quality to better manage project deliverables and timelines.
• Assist GMP Quality group in continuous improvement projects by participating in SOP revisions and process optimization.
• Maintain change control lists and assist in notification of change controls to Karyopharm’s global partners.
• Support review of batch documentation and analytical data review received from CDMOs (Contract Drug Manufacturing Organizations) for various manufacturing and testing operations of Karyopharm’s product.
• Assist GMP Quality with revision of Quality Technical Agreements with external vendors. This project will involve reviewing Quality Technical Agreements against approved Karyopharm template.

Candidate Profile & Requirements:

• Actively enrolled in a undergraduate or graduate programs in a scientific discipline
• Major in Pharmaceutical Sciences, Regulatory affairs is preferred
• Interest to learn highly regulated drug manufacturing process, analytical testing, and quality oversight..
• Strong verbal and written communication skills.
• Highly proficient with MS Office tools.
• Ability to learn and adapt with ambiguity of strengths.
• Work in a team setting adopting collaborative and learning approach for achieving results.
• Enthusiasm to learn new skills and Motivation towards career development.
• 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

Our Value Proposition:

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