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Senior Research Chemist

Company: Supernus
Location: Rockville
Posted on: June 17, 2022

Job Description:

Job Summary:To perform analysis of analytical samples to support preformulation studies (e.g., solubility or compatibility studies, release of raw materials, method validation, characterization of drug substance) in accordance with Supernus Standard Operating Procedures (SOPs) and FDA guidelines, and other various tasks.Essential Duties & Responsibilities* Perform sample analysis using different instruments such as HPLC, particle size analyzer, microscope* Perform release testing conducted at Supernus for raw materials API and packaging components* Plan and execute preformulation research experiments, such as solubility and compatibility studies* Validate analytical test method for testing of drug substances* Author validation protocols and technical reports* Interact with other departments and outside contractors* Maintains lab notebooks and logbooks in accordance with company SOPs designed to comply with cGxP.* Peer review of laboratory notebooks.Non-Essential Duties & Responsibilities:* Assists with the management of the retain samples and reference standards when needed* Assists with the calibration of laboratory instruments when necessary.* Assist with update and/or review of SOPs and test methods applicable to the group.* Assists with the development of analytical methods.* Assists with preparation of regulatory document (CMC sections relevant to raw materials, drug substance and packaging components).Supervisory Responsibilities:* N/AKnowledge & Other Qualifications:* Requires a MS or BS in Sciences (preferred Chemistry, Analytical Chemistry, or Pharmaceutical Sciences) with commensurate experience.* MS with 2+ years relevant experience, or BS with 4+ years relevant experience.* Good communication skills (written and verbal).* Strong organizational and prioritization skills to handle multiple tasks* Working knowledge of HPLC quantitative analysis and wet chemistry techniques.* Knowledge of regulated documentation and GMP/GLP is preferred.* Experience with analytical instruments such as DSC, TGA, microscope, particle size analyzer is a plus.* Detail oriented.* Basic computer skills - working knowledge of Microsoft - Word and Excel, knowledge of analytical instrument software(s) such as Empower is a plus.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.Working Conditions and/or Physical Requirements:* Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; the ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination* 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 terminal; and extensive reading* The worker is not substantially exposed to adverse environmental conditions* 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 and dust masks.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.

Keywords: Supernus, Rockville , Senior Research Chemist, Other , Rockville, Maryland

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