Senior Manager 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 outcomes.

Job Summary:

To manage bioanalytical activities including but not limited to method development, method validation, and sample analysis testing across all projects in accordance with Supernus Standard Operating Procedures (SOPs) and FDA guidelines. To supervise, provide leadership, train, and develop members of the bioanalytical sciences group.

Essential Duties & Responsibilities:

• Manage routine bioanalytical method development, method validation, and sample analysis testing in accordance with Supernus internal procedures (SOPs and test methods)
• Perform review and approval of data and reports generated by the bioanalytical group, ensuring appropriate processing of data in terms of integration, quantitation, data summaries, and run performance.
• Has advanced skills regarding biological sample preparation/extraction and method development to guide analysts for troubleshooting issues related to sample analysis.
• Manage all the BA laboratory operations (e.g., supplies, reference standards, waste disposal)
• Establish and maintain control systems to assure that the bioanalytical laboratory is operated in a manner consistent with cGxPs.
• Train all bioanalytical personnel on all laboratory activities and bioanalytical methods.
• Verbally communicates, effectively and concisely, complex technical issues to the bioanalytical group, other departments and when applicable to third parties.
• Write SOP's, development and technical reports, and other documents.
• Demonstrate success in technical proficiency, scientific creativity, collaboration with others, and independent thinking.
• Review of bioanalytical protocols and reports from contract laboratories.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Provide input on technical sections of regulatory filings.
• May represent the bioanalytical group on interdisciplinary project teams.
• Assist with review of bioanalytical protocols and reports from contract laboratories for the preclinical group.
• Assist with creation and management of budget for the bioanalytical group.
• Assist management with bioanalytical activities performed at contract laboratories.
• Assist management with review of instrument qualification, software validation, change controls, and related SOPs.
• May be a responder for alarms for Freezers and Ultralow freezers containing biological samples.

Supervisory Responsibilities:

• Manages the Bioanalytical group.
• 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 a degree in Sciences, Chemistry or Pharmaceutical Science preferred, with commensurate experience: Ph.D. with 4+ years relevant experience, MS with 7+ years relevant experience, or BS with 9+ years relevant experience.
• 2+ years of supervisory experience is preferred.
• Strong technical, interpersonal, communication and leadership skills.
• Strong organizational and prioritization skills to handle multiple tasks.
• Detail oriented.
• Strong working knowledge of biological sample extraction techniques.
• Working knowledge of mass spectrometry or LC-MS-MS.
• Strong knowledge of cGMP regulations, ICH, and FDA Guidance Documents.

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 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.

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 $120,000 to $145,000. 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 / 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.