Supernus Pharmaceuticals, Inc. · 3 days ago
Process & Technology Transfer Engineer I
Rockville, MD
Full-time
Hybrid
Entry Level
$73K/yr - $85K/yr
2+ years expSupernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. The Process and Technology Transfer Engineer I is responsible for supporting the technology transfer process to Contract Manufacturing Organizations and collaborating cross-functionally to contribute to formulation development and regulatory documentation for commercial manufacturing outcomes.
BiotechnologyHealth CarePharmaceutical
No H1B
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
Reviews manufacturing batch records, protocols, and technical reports
Supports project execution and process improvements goals and objectives
Recommends and implements equipment and manufacturing process to support successful process technology transfer, process registration, and validation
Perform statistical analyses, including Design of Experiments (DOE) and Statistical Process Control (SPC)
Authors and reviews 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 of clinical trial material
Writes and reviews 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
Other duties as assigned
Qualification
Required
Bachelors degree in engineering or related fields and a 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 with the use of data
Strong communication skills (written and verbal) are required
Proficiency with Microsoft office (Word, Excel, Outlook) required
Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality
Ability to have an innovative and dynamic approach to work
A self-starter able to work independently but comfortable working in a team environment
Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others
Authorized to legally work in the United States without visa sponsorship
Preferred
Previous experience working with Statistical models and conducting statistical analyses a plus
Benefits
Health
Dental
Vision
Paid time off
401k company match
Company paid life insurance
Health and wellness benefits
Stock equity awards
Employee stock purchase programs
Participation in our Company’s discretionary annual bonus program
Company
Supernus Pharmaceuticals, Inc.
We are a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$689.5MKey Investors
UBSNew Enterprise Associates
2023-02-14Post Ipo Debt· $150M
2018-03-13Post Ipo Debt· $350M
2013-04-24Post Ipo Debt· $90M
Leadership Team
J
Jack A. Khattar
President & CEO
F
Frank Mottola
Chief Technical Operations Officer
Recent News
2025-12-08
Company data provided by crunchbase