Process & Technology Transfer Engineer I

About the role

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience developing and commercializing products that treat central nervous system (CNS) diseases. The company develops innovative products for neurological and psychiatric conditions and currently has 8 products on the market impacting patient outcomes. The Process and Technology Transfer Engineer I supports a broad range of activities within the Drug Delivery Sciences Department, including technology transfer to Contract Manufacturing Organizations (CMOs), manufacturing scale‑up, process registration, process validation, oversight of CMO manufacturing operations, cross‑functional collaboration for in‑house formulation development, and preparation of technical and regulatory documentation for successful commercial manufacturing.

Responsibilities

• Oversee and lead the technology transfer process for Contract Manufacturing Organizations.
• Provide technical support for manufacturing scale‑up, process registration, and completion of process validation activities.
• Prepare and review study protocols and technical reports in accordance with regulatory and quality standards.
• Review manufacturing batch records, protocols, and technical reports.
• Support project execution and process improvement goals and objectives.
• Recommend and implement equipment and manufacturing process changes to support successful process technology transfer, registration, and validation.
• Perform statistical analyses, including Design of Experiments (DOE) and Statistical Process Control (SPC).
• Author and review equipment qualification documents, Standard Operating Procedures (SOPs), and work instructions.
• Collaborate cross‑functionally to support the manufacture of Clinical Trial Materials (CTM) and ensure timely delivery.
• Write and review relevant quality sections of regulatory filing documents (IND, NDA, Briefing packages, IMPD, CTA, etc.).
• Support early‑phase product and process development activities in collaboration with Drug Delivery Services.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in engineering or a related field.
• Minimum of two years of relevant industry experience in manufacturing, process development, scale‑up, technology transfer, and process validation.
• Previous experience writing equipment validation protocols or technical writing.
• Working knowledge of cGMP requirements related to drug product manufacturing processes.
• Demonstrated ability to solve complex technical problems using data.
• Experience with statistical models and conducting statistical analyses is a plus.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office (Word, Excel, Outlook).
• Authorized to legally work in the United States without visa sponsorship.

Other Characteristics

• Ability to work independently and as part of a team while maintaining high ethical standards of integrity and quality.
• Innovative and dynamic approach to work.
• Self‑starter who can work independently but is comfortable in a team environment.
• Consistently exhibit Supernus Values in interactions with employees, vendors, customers, and others.
• Capable of performing other duties as assigned by management.

Physical Requirements & Work Environment

• Sedentary work when not in the lab (sitting most of the time, exerting up to 10 lb force occasionally).
• When in the lab, exert up to approximately 50 lb force occasionally and/or up to 30 lb force frequently, and up to 10 lb force constantly to move objects.
• Requires close visual acuity for preparing/analyzing data, viewing screens, reading, operating machines, and performing mechanical or skilled trade tasks.
• Occasional work in a clean processing room; must wear personal protective equipment (gloves, safety glasses/goggles, face shields, lab coats, ear plugs, half‑mask air‑purifying respirator, powered air‑purifying respirator (PAPR), Tyvek suits).
• Tyvek suits can increase warmth and physical challenge.
• May