Senior QC Chemist

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 outcome.

Job Summary:

Responsible for performing testing pharmaceutical solid dosage forms for release and stability, using spectroscopy, HPLC and other analytical instrumentation; maintaining proper GMP documentation for logbooks and providing training and guidance to other QC chemists.

Essential Duties & Responsibilities:

• Perform testing (including dissolution, spectroscopy, HPLC analysis, and visual inspection).
• Initiation of quality records (e.g. deviation, OOS/OOT, change controls).
• Initiate and implement CAPA actions as needed.
• Support management in their responsibilities and tasks.
• Initiate or revise Standard Operating Procedures or Test Methods as needed.
• Maintain equipment logbooks in accordance with company guidelines designed to comply with cGMP.
• Utilize laboratory data systems for acquiring and processing data (e.g. Empower, LIMS, etc.).
• Perform data management, data review and report writing assignments as needed.
• Perform peer review of testing data.
• Initiate or revise Stability Summary reports.
• Schedule contract laboratory external testing activities with vendors.
• Ship samples for external testing.
• Perform assay troubleshooting as needed.
• Maintain data within company data integrity standards.
• Train personnel to perform analysis for pharmaceutical dosages.
• Manage workload and assignments in accordance with established timelines.
• Generate specifications and stability protocols in LIMS.
• Generate Certificates of Analysis as needed.
• Participate in assay transfer and assay qualification/validation activities as needed.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Calibration of laboratory instruments.
• Provide guidance and assistance to QC chemists.
• Performing chemical inventories.
• Manage stability studies in LIMS.

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• BS degree in Chemistry or other science-related discipline.
• 4+ years of practical related experience.
• Experience with HPLC testing required.
• Experience with GMPs is required.
• Experience with a Quality Management system is preferred.
• Ability to understand and follow written procedures.
• Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel.
• Knowledge of Good Documentation Practices and ALCOA+.
• Detail oriented, strong laboratory documentation skills.
• Strong communication and technical writing skills in English language.
• Ability to accept personal accountability for successful job performance.
• Ability to work efficiently and accurately to meet set goals and timelines, and ability to pay attention to detail.
• Ability to work in a fast paced and flexible work environment where priorities can change.

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 carry 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.
• 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 mask to include respirators.

Compensation:

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 to $90,000. 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.

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