Process & Technology Transfer Engineer I

Job Summary

The Process and Technology Transfer Engineer I supports the Drug Delivery Sciences Department by overseeing and leading the technology transfer process for Contract Manufacturing Organizations (CMOs). Responsibilities include supporting manufacturing scale up, process registration, and process validation activities, and collaborating cross-functionally to prepare technical and regulatory documents.

Essential Duties & 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.
• Performs 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.
• Collaborates 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.).
• Supports early phase product and process development activities in collaboration with Drug Delivery Services.
• Other duties as assigned.

Knowledge & Other Qualifications

• Bachelor's 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.

Supervisory Responsibilities

N/A

Physical Requirements/Work Environment/Travel Requirements

• Sedentary work, when not working in the lab.
• Exerting up to 10 pounds of force occasionally and/or carrying objects.
• Close visual acuity to perform activities such as preparing and analyzing data and figures; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• Exerting up to approximately 50 pounds of force occasionally and/or up to 30 pounds of force frequently, as well as exerting up to 10 pounds of force constantly to move objects, when working in the lab.
• May be required to wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits occasionally.
• Will be required to work in a clean processing room environment occasionally and wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits occasionally.
• May be required to work and exert force while wearing Tyvek suits when working in the lab, which can make conditions warmer, and more challenging.
• Employees will be required to work and exert force while wearing Tyvek suits.
• Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, kneeling, crouching, walking and pushing.
• Travel requirements are project and phase dependent. Phase 2 or small-scale process technology transfers may require 20-40% of travel a month. Large-scale technology transfers, scale up, registration and validation may require 50-90% of travel a month.

Compensation

• The expected salary range for fully qualified candidates applying for this role is $73,000 to $85,000.
• This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role.
• This range may be modified in the future.
• An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
• You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits.
• The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company’s discretionary annual bonus program.

About the Role

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.

Qualifications

• Bachelor's degree in engineering or related fields.
• 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.

Skills

• Statistical analysis
• Equipment qualification
• Standard Operating Procedures (SOPs)
• Collaboration
• Technical writing
• Process validation
• Quality control
• Regulatory compliance
• Manufacturing process management

Benefits

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $73,000 to $85,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company’s discretionary annual bonus program.

Pay

• The expected salary range for fully qualified candidates applying for this role is $73,000 to $85,000.
• This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role.
• This range may be modified in the future.
• An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

Schedule

• Sedentary work, when not working in the lab.
• Exerting up to 10 pounds of force occasionally and/or carrying objects.
• Close visual acuity to perform activities such as preparing and analyzing data and figures; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• Exerting up to approximately 50 pounds of force occasionally and/or up to 30 pounds of force frequently, as well as exerting up to 10 pounds of force constantly to move objects, when working in the lab.
• May be required to wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits occasionally.
• Will be required to work in a clean processing room environment occasionally and wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits occasionally.
• May be required to work and exert force while wearing Tyvek suits when working in the lab, which can make conditions warmer, and more challenging.
• Employees will be required to work and exert force while wearing Tyvek suits.
• Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, kneeling, crouching, walking and pushing.
• Travel requirements are project and phase dependent. Phase 2 or small-scale process technology transfers may require 20-40% of travel a month. Large-scale technology transfers, scale up, registration and validation may require 50-90% of travel a month.