Senior Process Engineer, Technical Operations

Overview

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. We currently have 8 products in the market that are making a real impact on patient outcomes.

The Senior Process Engineer is responsible for supporting the Technical Operations department through process development, optimization, and technology transfer activities. This role performs a broad range of functions, including designing and conducting experiments, authoring sections of regulatory submission documents, and implementing innovative solutions to support patent applications. In addition, this role will provide support junior - level personnel by providing training, guidance and, and technical oversight.

• Lead and support dosage form manufacturing process development activities in compliance with applicable GMP requirements.
• Serves as the Subject Matter Expert for technical and technology transfer activities to Contract Manufacturing Organizations (CMOs).
• Participate in process validation activities, including the review of validation protocols and reports.
• Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques, and production yields for existing products.
• Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) targeting physical cause of failure.
• Works cross-functionally with Quality Assurance and GMP Operations to lead the manufacture of Clinical Trial Materials (CTM).
• Writes equipment SOPs, study protocols, technical reports, and equipment qualification documents.
• Demonstrates technical proficiency across a broad range of manufacturing equipment and processes.
• Prepares appropriate sections of regulatory submission documents, including INDs, NDAs, Briefing packages, IMPD, CTA, and related items.
• Mentors and/or supervise junior personnel in equipment use and manufacturing process development.
• Other duties as assigned.

• Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives.
• Understands Company Policy and procedure to be able to guide direct reports appropriately.

• Bachelor of Science with a minimum of six years of relevant industry experience in manufacturing, process development, scale-up, technology transfer and process validations.
• Masters in Pharmaceutics, Chemical engineering, or related field. or equivalent combination of education and experience with four years' relevant pharmaceutical or GMP experience.
• Ph.D. in a relevant subject and zero years of experience.

• 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.

• 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,…