Process & Technology Transfer Engineer I

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

Job summary

Supernus Pharmaceuticals, Inc. is seeking a Process and Technology Transfer Engineer I to support technology transfer to CMOs, scale-up, and validation efforts within the Drug Delivery Sciences Department.

The role involves collaboration across functions to contribute to in-house formulation development and regulatory documentation for successful commercial manufacturing outcomes.

Qualifications

• Bachelor's degree in engineering or related field and 2+ years of relevant industry experience.
• Experience writing equipment validation protocols or technical writing.
• Working knowledge of cGMP for Drug Product manufacturing.
• Strong data-driven problem solving and analytical skills.
• Excellent written and verbal communication; proficient with MS Office.

Responsibilities

• Lead and support technology transfer for Contract Manufacturing Organizations (CMOs).
• Assist 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.
• Recommends and implements equipment and manufacturing processes to support transfer, registration, and validation.
• Perform statistical analyses, including DOE and SPC.
• Authors and reviews equipment qualification documents, SOPs, and work instructions.
• Collaborate cross-functionally to support CTM manufacture and regulatory filings.

Skills

Strong communication skills

Microsoft Office proficiency

Data analysis

Problem solving with data

DOE/ SPC knowledge

cGMP knowledge

Education

Bachelor's degree in engineering or related field

Tools

SOPs

Job description

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.

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.
• 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.

Supervisory Responsibilities

• N/A

Knowledge & Other Qualifications

• 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.

Other Characteristics

• 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 performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements

• Sedentary work, when not working in the lab. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time.
• When in the lab, employees will be required to exert 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.
• The employee is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is also required to have the visual acuity to perform activities such as operating machines, and to perform mechanical or skilled trade tasks of a non-repetitive nature.
• 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.
• The employee is not substantially exposed to adverse environmental conditions on a regular basis. Employees may have to wear 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

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.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.