Supervisor, Laboratory Services

Job Summary:

To coordinate and supervise the calibration, qualification, and preventative maintenance of all laboratory instruments for the Analytical Science (AS) and Quality Control (QC) departments and manufacturing equipment for the Drug Delivery Sciences (DDS) department.

Essential Duties & Responsibilities:

• Calibrate and/or review calibrations for a variety of laboratory instruments to ensure compliance with specifications (e.g., HPLCs, dissolution units, Karl Fisher units, environmental chambers).
• Calibrate and/or review calibrations for a variety of manufacturing equipment to ensure compliance with specifications (e.g., ovens, blenders, fluid bed granulator).
• Perform and/or review routine installation, qualification, maintenance, and repair on laboratory instruments and manufacturing equipment.
• Write qualification documents for laboratory instrumentation and manufacturing equipment.
• Write or update procedures (SOPs) concerning instrumentation and equipment when needed.
• Communicate with contractors regarding scheduling, timelines and documentation expectations.
• Investigate and troubleshoot out of calibration results.
• Initiate deviations and/or review deviations when needed.
• Responsible for maintaining the calibration database and oversight of the calibration schedule.
• Responsible for responding to temperature or humidity excursions during or outside normal business hours.
• Tracking of key performance indicators
• Provide calibration and/or instrument use training to laboratory personnel, as applicable.
• Assist with requesting vendor quotations for services, review of contracts, and general vendor correspondences.

Non-Essential Duties & Responsibilities:

• Drafting qualification documentation
• Review of technical reports on environmental monitoring system
• Perform risk assessments for change controls

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• B.S. in Chemistry, Engineering with 5+ years of experience or high school degree or relevant technical school training/certification with 8+ years of relevant experience.
• Knowledge of laboratory instrumentation is required.
• Knowledge of manufacturing equipment is a plus.
• Strong organizational skills with attention to detail.
• Excellent interpersonal and communication skills.
• Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel.
• GMP experience is required.
• Experience with a Quality Management system is preferred.
• Previous supervisory experience is preferred.

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. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker 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 not substantially exposed to adverse environmental conditions

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.