Technology Transfer Engineer I - Drug Delivery Scaling

Supernus Pharmaceuticals Inc; Rockville (MD); On-site; USD 73,000 - 85,000; Full time

Job summary

Supernus Pharmaceuticals is seeking a Process & Technology Transfer Engineer I to support technology transfer to CMOs, scale-up, validation, and regulatory documentation. The role requires cross-functional collaboration to advance in-house formulation development and commercial manufacturing readiness.

The successful candidate will oversee tech transfer activities, review batch records, and contribute to process improvements while ensuring adherence to regulatory and quality standards.

Qualifications

• Bachelor's degree in engineering or related field with 2+ years of relevant experience in manufacturing, process development, scale-up, technology transfer and validation.
• Experience writing equipment validation protocols or technical writing.
• Knowledge of cGMP requirements for Drug Product manufacturing.
• Strong analytical and data-driven problem solving.
• Excellent written and verbal communication skills; proficient with MS Office (Word, Excel, Outlook).

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 improvements goals and objectives.
• Collaborate cross-functionally to support CTM manufacture and timely delivery of clinical material.

Skills

Communication skills

cGMP knowledge

Technical writing

DOE and SPC

Microsoft Office

Statistical analysis

Education

Bachelor's degree in engineering or related fields

Job description

Supernus Pharmaceuticals is seeking a Process & Technology Transfer Engineer I to support technology transfer to CMOs, scale-up, validation, and regulatory documentation. The role requires cross-functional collaboration to advance in-house formulation development and commercial manufacturing readiness.

The successful candidate will oversee tech transfer activities, review batch records, and contribute to process improvements while ensuring adherence to regulatory and quality standards.