Senior QC Chemist

Supernus Pharmaceuticals, Inc.; Rockville (MD); On-site; USD 77,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior QC Chemist to manage quality control processes for commercial biologics and solid dosage forms. The ideal candidate will have experience with GMP standards and a strong background in scientific principles. This role involves ensuring compliance and offering guidance to junior staff in a non-regulated laboratory environment.

Qualifications

• Minimum of four years of relevant experience.
• Experience in FDA-regulated environment preferred.
• Knowledge of FDA and cGMP regulations.

Responsibilities

• Manages external QC testing and supports internal QC testing.
• Performs data review for biologics products.
• Reviews and updates SOPs and test methods.

Skills

Technical skills

Communication

Attention to detail

Education

Bachelors in Biological Sciences, Chemistry or related discipline

Job description

Join to apply for the Senior QC Chemist role at Supernus Pharmaceuticals, Inc.

Join to apply for the Senior QC Chemist role at Supernus Pharmaceuticals, Inc.

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

The Senior Chemist of Quality Control (QC) is responsible for providing support for commercial biologics products and solid dosage pharmaceutical forms. Individuals in this role ensure proper Good Manufacturing Process (GMP) documentation and provide support to junior level QC chemists.

Essential Duties & Responsibilities

• Manages external QC testing of commercial products and supports internal QC testing of pharmaceutical dosage forms (including but not limited to dissolution testing, spectroscopy, HPLC and GC analysis, and wet chemistry).
• Perform data review for biologics products and pharmaceutical dosage forms.
• Schedules contract laboratory external testing activities with vendors for commercial products.
• Participates in weekly meetings and collaborates with external vendors and CMOs. Works with external vendors and CMOs including participation in weekly meetings.
• Perform data management ensuring adherence to company data integrity standards.
• Creates ad-hoc reports as requested by management.
• Manages, initiates, and revises stability reports.
• Reviews, writes, and updates company Standard Operating Procedures (SOPs) and test Methods.
• Perform deviation and laboratory OOS/OOT investigations as needed.
• Manages shipment of samples for external testing.
• Performs assay troubleshooting as needed.
• Generates specifications and stability protocols in LIMS.
• Generate Certificates of Analysis as needed.
• Supports assay transfer and assay qualification/validation activities as needed.
• Provides guidance and assistance to lower-level QC chemists.
• Perform laboratory testing on pharmaceutical dosage forms as needed.
• Other duties as assigned.
  
  

Non-Essential Duties & Responsibilities

• N/A
  
  

Supervisory Responsibilities

• N/A
  
  

Knowledge & Other Qualifications

• Bachelors in Biological Sciences, Chemistry, or a related scientific discipline with a minimum of four years of relevant experience.
• Experience with investigative techniques including OOS methodology, root cause analysis and statistical sampling.
• Experience working with pharmaceutical dosage form analysis techniques (e.g., HPLC, dissolution, spectroscopy, wet chemistry, and physical testing) is preferred.
• Experience in an FDA-regulated biotechnology, pharmaceutical company is preferred.
• Working Knowledge of FDA and cGMP regulations is preferred.
• Knowledge of LabWare LIMS system and Environmental Monitoring (EM) is preferred.
• Strong technical, interpersonal, communication and leadership skills.
  
  

Other Characteristics

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• 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.
• Strong written and verbal communications skills.
• Strong attention to detail.
• Ability to organize and prioritize multiple tasks.
• 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

• Requires some standing during laboratory work and occasionally lifting up to 10 pounds.
• Requires close visual acuity to perform activities including visual inspection, preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• No substantial exposure to adverse environmental conditions.
• May be required to work in a laboratory environment 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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