Tech Transfer Engineer I - Process Scale-Up & Validation

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

401k match

Stock equity awards

Employee stock purchase program

Job summary

Supernus Pharmaceuticals, Inc. is seeking a Process & Technology Transfer Engineer I to support technology transfer to CMOs, scale-up, and process validation in Drug Delivery Sciences.

This role collaborates cross-functionally to advance in-house formulation development and regulatory documentation. Responsibilities include leading tech transfer for CMOs, preparing protocols, reviewing batch records, performing DOE and SPC analyses, and drafting quality sections for IND/NDA filings.

Qualifications

• BS in engineering or related field required.
• Minimum two years in manufacturing, process development, scale-up, technology transfer and process validation.
• Experience writing equipment validation protocols or technical writing preferred.
• Knowledge of cGMP requirements for Drug Product manufacturing.

Responsibilities

• Oversee technology transfer for Contract Manufacturing Organizations.
• Support scale-up, process registration, and validation activities.
• Prepare and review study protocols and technical reports per regulatory standards.
• Review manufacturing batch records, protocols, and technical reports.
• Collaborate cross-functionally to support CTM manufacture and regulatory filings.
• Write/review quality sections of regulatory filings (IND, NDA, IMPD, CTA, etc.).
• Perform DOE and SPC analyses.
• Create/maintain equipment qualification documents and SOPs.

Skills

DOE

SPC

Data analysis

Communication

Education

Bachelor's degree in engineering

Tools

Microsoft Office

Job description

Supernus Pharmaceuticals, Inc. is seeking a Process & Technology Transfer Engineer I to support technology transfer to CMOs, scale-up, and process validation in Drug Delivery Sciences.

This role collaborates cross-functionally to advance in-house formulation development and regulatory documentation. Responsibilities include leading tech transfer for CMOs, preparing protocols, reviewing batch records, performing DOE and SPC analyses, and drafting quality sections for IND/NDA filings.