Process & Technology Transfer Engineer

Process & Technology Transfer Engineer I

Job Category
:
Drug Delivery Sciences

Requisition Number
: PROCE
001733

• Full-Time
• On-site

Rockville, MD 20850, USA

Supernus 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. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Process and Technology Transfer Engineer I is responsible for supporting a broad range of activities within the Drug Delivery Sciences Department. Incumbents in this role will support the technology transfer process to Contract Manufacturing Organizations (CMOs). This role will support manufacturing scale up, process registration, and process validation activities, including providing oversight of manufacturing operations within CMOs. This position will also collaborate cross functionally to contribute to in-house formulation development and the preparation of technical and regulatory documentations for successful commercial manufacturing outcomes.

• 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.

• N/A

• 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.
• Previous experience working with Statistical models and conducting statistical analyses a plus.
• 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.
• Capable of…