Summer Intern – GMP Quality

Karyopharm Therapeutics • Newton, MA

20h

About The Position

As a Karyopharm, reporting to the Executive Director , GMP (Good Manufacturing Practice) Quality, you will positively impact patients’ lives by: Assisting with Quality Unit (QU) efforts and activities within the organization and the Contract Service Providers, including the development and implementation of the programs. You will provide help to GMP Quality and Quality Management S ystems teams , in support of the Annual G MP Quality Management Review (QMR) , training program improvements, Veeva Vault processes and other ancillary quality activities.

Requirements

• Enrolled into undergraduate or graduate programs in scientific disciplines with interest to learn highly regulated drug manufacturing process , analytical testing, and quality oversight.
• Good Oral 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.
• Must be able to complete the Karyopharm I nternship Program 27 May – 08 Aug 2025
• Current ly enrolled high school or college ( bachelor’s program) student
• Student must be returning to school in the Fall Term.
• Must have a minimum GPA of 3.0
• Must be highly organized and have the ability to work in independently and collaboratively as a team
• Clear, concise verbal & written communication

Nice To Haves

• Previous experience in Pharmaceutical or Biotech organizations is desired but not

Responsibilities

• Assist GMP in data collection and report generation for Annual Quality Management Review (QMR) . This project will require creation of excel lists, statistical analysis, and technical writing. This will give an individual overview of drug manufacturing and testing processes along with affiliated regulations and guidelines.
• Assist in management of minor product quality investigations in Veeva Vault. This project will require individuals to learn and execute documentation for quality event investigations.
• Develop Smartsheet s and trackers for GMP Quality to better manage project deliverables and timelines.
• Assist GMP Quality group in continuous improvement project s by participating in SOP revisions and process optimization.
• Maintain deviation and change control lists and assist in notification of change controls to Karyopharm’s global partners.
• Provide communication support for training notifications and scheduling training for Karyopharm’s business partners .
• Assist Quality Management Systems team with revision of the training management program including updating training matrices, creating excel of GxP processes; training requirements and required training per functional team in support of Veeva configuration updates.
• 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.

What This Job Offers

• Career Level: Intern
• Number of Employees: 251-500 employees