Intern - CMC

The CMC (Chemistry, Manufacturing and Controls) intern will primarily assist the assigned department with a variety of duties, ranging from completing administrative tasks to supporting/continuing implementation of existing programs and systems, to shadowing team members in strategic discussions. The intern will be involved in project-based work that will allow them the opportunity to learn in a corporate environment at a pharmaceutical company. In general, the intern will be encouraged and expected to offer recommendations for process improvements/enhancements on all matters. The intern, in collaboration with SKLSI team members, will develop goals at the beginning of the internship. The intern will take on an active support role and should be comfortable asking questions and taking initiative in order to best enhance their contributions to SKLSI and their own educational experience. Assignment of responsibilities will be commensurate with demonstrated abilities, and where possible, will be aligned with the intern's goals. This is a paid internship located at the Paramus, NJ facility.

Archiving study specific documents in the system, prepare lists of archived documents (15 hours per week)
• Perform data QC of the tables in NDA module 3 for cenobamate oral suspension (10 hours per week)
• Prepare lists of relevant documents that are supporting for OS NDA (5 hours/week)
• Create regulatory guidance database with some of the important guidance documents and read understand some of them (5 hours/week)
• Create standard costs table for better estimates for forecasting (3 hours per week)
• There might be some document shredding involved for hard copies, print outs, arranging folders (2 hour per week)
• Understands the overall concept of the company, including the brand, customer, product goals, and other aspects of the business.
• Provides ideas to grow and improve the business
• Accepts designated, business-focus tasks and/or projects to research, propose ideas and solutions, and present final project during the internship.
• Provide suggestions to management for improving internal processes
• Learns and becomes proficient on internal systems
• Must be organized and able to effectively multitask
• Strong interpersonal relationship skills and has the demonstrated ability to establish and maintain positive relationships with stakeholders.
• Prepare applicable documents as needed
• Respond to requests from leadership to support various projects and initiatives that may arise.
• Maintain clear communication with colleagues and Department Head.
• Perform administrative tasks as needed

• Intern must also be enrolled in and maintain enrollment at an accredited College/University with a scientific discipline (preferabley Chemistry)
• Proficient in Microsoft Office and general computer skills.
• Highly organized with strong focus on accuracy
• Ability to work well unsupervised and have
• Excellent interpersonal and communication skills
• Ability to work in a small entrepreneurial company
• Excellent written and verbal communication skills
• Self-directed and able to work without supervision
• Energetic and eager to tackle new projects and ideas
• Ability to work both independently and as part of a team.
• Interest in biotech
• Strong desire to gain hands-on experience in a fast-paced biotech organization