Summer Intern - Manufacturing Development, Formulations

At Harmony Biosciences, we specialize in developing and delivering treatments for rare neurological diseases that others often overlook. We believe that where empathy and innovation meet, a better life can begin for people living with neurological diseases. Our team of experts from a wide variety of disciplines and experiences is driven by our shared conviction that innovative science translates into therapeutic possibilities for patients, who are at the heart of everything we do.

Harmony Biosciences culture is defined by our core values - keeping patients at the heart of all we do, acting with integrity and ethics, working with a one-team attitude, leading with the science as we identify clinical possibilities, and delivering excellence.

This summer internship at Harmony offers a unique perspective into a rare-disease focused biotech company. Our internship program will provide you the opportunity to work on real-world projects, as well as network with people at Harmony through various events and activities.

This position will work on the Manufacturing Development, Formulations team at Harmony.

Manufacturing Development is responsible for:

• Direct oversight of multiple drug product development programs of diverse dosage forms for adult and pediatric indications.
• Providing scientific technical expertise for CMC activities for early and late-stage programs leading to the manufacture of clinical trial material to support life cycle management and new programs.
• Designing project plans for pre-formulation, formulation, and process development/optimization, and scale-up, in a phase-appropriate manner and executing them via contract service providers/partners in compliance with regulatory guidelines.

This internship will work on one or more projects in the areas of:

• Literature Review: Conduct comprehensive literature search and review to support existing research and provide valuable insights for ongoing projects, e.g. role of polymorphism in oral solution drug product development, oral solid dosage forms for pediatric use, etc.
• Data Collection and Analysis: Compile, review, and analyze data related to drug product development studies using relevant tools and software.
• Documentation: Maintain detailed records, contribute to technical reports and product summaries, and present project study results.
• Execution: Support the management of clinical batch manufacturing at the CDMO's and maintain batch manufacturing summary.
• There may also be other projects and initiatives within the team that may require support.

Requirements:

• Minimum age for all candidates must be at least 18 years or older.
• Must be enrolled in an accredited college or university as a junior or senior, or in a master's degree program. Science major or pharmaceutical orientation preferred.
• Must be proficient in use of MS Excel, MS SharePoint/Teams.
• Passion for research and development, and desire to contribute to the advancement of knowledge.
• Excellent analytical and critical thinking skills. Strong attention to detail and ability to maintain organized records.
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
• Candidates must have strong written and verbal communication skills.

Physical Demands and Work Environment:

• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.

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Preferred