Senior Manager, Pre-Formulation Sciences (Analytical Sciences)

Essential Duties & Responsibilities

• Manage analytical support for the drug substances of assigned development projects at Supernus (API characterization, method development and validation, release testing).
• Manage the release testing of materials used for manufacturing activities conducted at Supernus (e.g., coordinate testing, perform review of sample testing and analytical reports).
• Conduct laboratory investigations for OOS and OOT.
• Review analytical method verification reports, validation protocols/reports, technical reports and associated raw data.
• Manage PFS laboratory studies performed at Supernus, such as solubility, forced degradation and compatibility studies.
• Manage the contract laboratories that perform PFS activities (e.g., API characterization, API method development and transfer, identification of impurities).
• Prepare or review CMC sections relevant to raw materials, API and packaging components for Regulatory Submissions.

Non-Essential Duties & Responsibilities

• Provide assistance for non-assigned development projects if needed.
• Aid in calibration/qualification of laboratory instruments.
• Aid in preparation of PFS budget.
• Identify new processes/techniques to increase efficiencies and expand capabilities of PFS activities performed at Supernus and oversee/manage the implementation.

Supervisory Responsibilities

• 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.
• Well-versed in instrumental methods, techniques and theory used in pharmaceutical analysis (e.g., HPLC, spectroscopy, wet chemistry, and physical testing).
• Expertise with regulatory filing is a plus.
• Strong, 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.
• 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.

Physical Requirements/Work Environment/Travel Requirements

• Sedentary work.
• Exerting up to 10 pounds of force occasionally and/or carrying 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.

Compensation

• The expected salary range for fully qualified candidates applying for this role is $130,000 to $150,000.
• 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.