QC Chemist

Supernus Pharmaceuticals; Rockville (MD); On-site; USD 50,000 - 60,000; Full time

Job summary

Supernus Pharmaceuticals is seeking an experienced QC/Analytical Scientist to perform dissolution and HPLC testing for solid dosage forms, ensuring compliance with cGMP and maintaining QA documentation. You will support CAPAs, SOP revisions, and data management in a fast-paced lab environment.

The role requires a bachelor's in chemistry or related field, 1+ year of relevant experience, and strong writing skills in English. Experience with Empower/LIMS is preferred.

Qualifications

• Bachelor's degree in Chemistry or related science required.
• 1+ years of practical related experience preferred.
• Experience with HPLC and/or dissolution testing preferred.
• Experience with GMPs, GCPs, and/or GLPs preferred.
• Knowledge of Good Documentation Practices and ALCOA+.
• Detail oriented with strong laboratory documentation skills.
• Strong communication and technical writing skills in English.
• Ability to work independently and in a team.

Responsibilities

• Initiation of quality records (e.g. deviation, OOS/OOT).
• Perform CAPA actions as assigned by management.
• Support senior staff members in their responsibilities and tasks.
• Revise SOPs or Test Methods as needed.
• Perform testing (dissolution, spectroscopy, HPLC, visual inspection).
• Maintain equipment logbooks per cGMP guidelines.
• Utilize lab data systems for data acquisition/processing (e.g. Empower, LIMS).
• Perform data management, data review and report writing as needed.
• Support senior staff and maintain data integrity.

Skills

HPLC

Dissolution testing

GMPs/GCPs/GLPs

Good Documentation Practices

ALCOA+

Lab documentation

English writing

Analytical chemistry

Independence

Education

Bachelor's degree in Chemistry or related science

Tools

Empower

LIMS

Job description

Description

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. 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 outcomes.

Job Summary:

Responsible for performing testing pharmaceutical solid dosage forms for release and stability, primarily by dissolution, and HPLC; maintaining proper GMP documentation for logbooks and report writing as necessary.

Essential Duties & Responsibilities:

• Initiation of quality records (e.g. deviation, OOS/OOT).
• Perform CAPA actions as assigned by management.
• Support senior staff members in their responsibilities and tasks.
• Revise Standard Operating Procedures or Test Methods as needed.
• Perform testing (including dissolution, spectroscopy, HPLC analysis, and visual inspection).
• 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.
• Supports senior staff members in their responsibilities and tasks.
• Maintain data within company data integrity standards.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Calibration of laboratory instruments.
• Performing chemical inventories.
• Serve as a backup for training activities to newer employees.

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• Bachelors degree in Chemistry or other science-related discipline.
• 1+ years of practical related experience preferred.
• Experience with HPLC and/or dissolution testing preferred.
• Experience with GMPs, GCPs, and/or GLPs is preferred.
• 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 $50,000 to $60,000. 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.

You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.

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.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.