Senior Scientist Analytical Sciences BA

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:  

To plan and provide key elements of bioanalytical (BA) support including but not limited to initiating, leading and executing development/validation of bioanalytical methods, managing/executing bioanalysis of clinical and non-clinical study samples, and providing leadership and guidance to junior BA analysts.

Essential Duties & Responsibilities:

• Conduct and manage routine and advanced BA sample analysis testing in accordance with Supernus Pharmaceuticals, Inc. (Supernus) Standard Operating Procedures (SOPs) and test methods.
• Independently develop rugged, sensitive, and reproducible bioanalytical assays (including extraction of drug/metabolite from biological matrix samples and analysis by LC-MS/MS).
• Independently design and conduct validation of BA methods as lead scientist.
• Troubleshoot instrumentation and/or bioanalytical assay related problems.
• Act as lead scientist for BA sample analysis and represents Bioanalytical Sciences in meetings for the corresponding clinical/nonclinical studies.
• Write SOPs, test methods, technical reports and other documents related to bioanalysis.
• Interact with other departments and outside contractors.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Assist management with review of BA section of clinical protocols and preparation of BA technical section(s) for regulatory submissions.
• Perform other tasks as needed; for example, may be a responder for alarms for Freezers and Ultralow freezers containing biological samples and may assist with additional laboratory duties (e.g., reference standard inventory, waste/biohazard disposal).

Supervisory Responsibilities:

• Provide leadership/guidance to junior BA analysts and assist in training & development.
• May supervise junior BA staff but their main role is a technical individual contributor.
• Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives.
• Understands Company Policy and procedure to be able to guide direct reports appropriately.

Knowledge & Other Qualifications:

• Requires BS or MS or PhD in Sciences (preferred Chemistry, Analytical Chemistry, Life Sciences or Pharmaceutical Sciences).
• PhD with 2+ years of relevant experience, MS with 6+ years of relevant experience, or BS with 8+ years of relevant experience.
• Well-versed in instrumental methods, techniques and theory used in bioanalysis, for example:
  • Has advanced skills regarding biological sample preparation/extraction.
  • Has advanced skills regarding development of LC-MS/MS assay, skillful at troubleshooting and maintaining LC-MS/MS instruments.
• Strong analytical thinking and problem-solving skills, and highly motivated.
• Good communication skills (written and verbal).
• Strong organizational and prioritization skills to handle multiple tasks.
• Detail oriented.
• Working knowledge of regulated documentation and GMP/GLP is a plus.
• Ability to network with senior internal and external representatives in own area of expertise.

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:

• 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 extensiv