Formulation Scientist

Job Summary: Performs a wide variety of tasks in the Drug Delivery Sciences department including, but not limited to, designing and conducting studies in support of Supernus' pipeline products, leading the manufacturing of GMP clinical supplies, participating in on site technical transfer/scale-up activities of bulk drug product manufacturing processes and/or primary packaging processes at contract development and manufacturing organizations (CDMOs), assisting with secondary clinical trial material packaging at CDMOs, writing SOP's, study protocols and technical writing sections of INDs

Essential Duties & Responsibilities:

• Designs and conducts, or supervises studies to develop drug products, including but not limited to immediate release, extended-release, enhanced solubility, and enhanced bioavailability.
• Maintains documentation consistent with current GMPs guidelines.
• Leads production of cGMP clinical supplies.
• Writes equipment SOP's, technical reports, and equipment qualification documents.
• Is a subject matter expert on pharmaceutical processes and process equipment and demonstrates capability with a wide variety of equipment and processes.
• Writes appropriate sections of INDs and other regulatory documents.
• Mentors and/or supervises junior personnel in drug product designs, process equipment, techniques, and processes.
• Demonstrates critical thinking and practical problem solving techniques related to specific project hurdles.
• Participates on site in the technical transfer/scale-up activities of drug products and manufacturing processes CDMOs.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• N/A

Supervisory Responsibilities:

• May provide leadership over personnel in the Drug Delivery Sciences group in an effective manner to accomplish corporate objectives.
• Understands Company Policy and procedure to be able to guide direct reports appropriately.

Knowledge & Other Qualifications:

• Ph.D with 0+ years relevant pharmaceutical and/or GMP experience with emphasis on manufacturing, process development, scale-up, technology transfer and process validations
• MS in Pharmaceutics, Chemical Engineering, etc. with min 4+ years relevant pharmaceutical and/or GMP experience or equivalent combination of education and experience.
• BS in Pharmaceutics, Chemical Engineering, etc. with min 6+ years relevant pharmaceutical and/or GMP experience or equivalent combination of education and experience.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having 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 development labs or GMP suites. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time.
• When in the development labs or GMP suites, employee 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 exert up to 10 pounds of force constantly to move objects.
• The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; 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 GMP processing room environment that requires wearing 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.
• The employee is not substantially exposed to adverse environmental conditions on a regular basis. Employee may have to wear Tyvek suits when working in the development labs or GMP suites, which can make conditions, warmer, and more challenging. Employee 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.

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 $77,000 - $98,000. 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.

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.

Limitations and Disclaimer:

The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees we be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an "at-will" basis.

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