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PROCESS ENGINEERING FELLOW

Supernus
Rockville, MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
 

Job Summary: 

This is a technical track, skilled position that provides technical leadership in supporting the manufacture of commercial products. It involves oversight of manufacturing activities at CMO. It also involves authoring, reviewing and approving technical documents such as study protocols, reports. This position works closely with quality in batch record review, deviations and investigations. This position also works closely with RA in providing RA the necessary technical support in their assessment of manufacturing changes. It requires a high level of training and experience.  

Essential Duties & Responsibilities:

  • Provides technical support in the manufacturing of Supernus’ commercial products
  • Leads technology transfer and process validation activities
  • Recommends and implements equipment and manufacturing 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 Controls (SPC)
  • Manages Continuous Process Verification (CPV) programs through trend analysis and reporting
  • Leads the manufacture of Clinical Trial Materials (CTM). Works cross-functionally with other departments such as Quality Assurance and GMP Operations in the manufacture of CTM. 
  • Writes and reviews equipment SOP’s, study protocols, technical reports, and equipment qualification documents.
  • Writes and reviews appropriate sections of regulatory filing documents (IND, NDA, Briefing packages, IMPD, CTA, etc.).
  • Mentors and supervises junior staff
  • Demonstrates critical thinking and practical problem-solving techniques related to specific project hurdles.
  • Other Duties as Assigned 

Non-Essential Duties & Responsibilities:

  • N/A 

Supervisory Responsibilities:

  • Supervise junior staff

Knowledge & Other Qualifications:

  • BS, MS or Ph.D in Pharmaceutics, Chemical engineering, or other relevant fields of study or equivalent combination of education and experience as stated below.
  • BS with at least 8 years of relevant industry experience in manufacturing, process development, scale-up, technology transfer and process validations.
  • MS with at least 6 years relevant pharmaceutical and/or GMP experience with emphasis on manufacturing, process development, scale-up, technology transfer and process validations.
  • Ph.D with at least 4 years relevant pharmaceutical and/or GMP experience with emphasis on manufacturing, process development, scale-up, technology transfer and process validations.

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 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, 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, 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; transcribing; viewing a computer terminal; 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 and/or sterile laboratory environment occasionally, and wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, aprons, ear plugs, dusk masks and Tyvek suits occasionally. 
  • 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 lab, 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. 

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.

 


Supernus

Address

Rockville, MD
20850 USA

Industry

Manufacturing

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