Senior Manager, Pre-Formulation Sciences (Analytical Sciences)

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: 

To manage Preformulation Sciences activities assigned development projects, this includes but is not limited to API characterization, method development, method validation, reviewing/approving procedures/protocols and technical reports, and preparation of regulatory documents. To supervise, provide leadership, train and develop the members of the PFS group.

Essential Duties & Responsibilities:

• For assigned development projects, manage analytical support for the drug substances of assigned development projects at Supernus (API characterization, method development and validation, release testing).For assigned development projects, 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).
• For assigned development projects, conduct laboratory investigations for OOS and OOT.
• For assigned development projects, review analytical method verification reports, validation protocols/reports, technical reports and associated raw data.
• For assigned development projects, manage PFS laboratory studies performed at Supernus, such as solubility, forced degradation and compatibility studies.
• For assigned development projects, manage the contract laboratories that perform PFS activities (e.g., API characterization, API method development and transfer, identification of impurities).
• For assigned development projects, prepare or review CMC sections relevant to raw materials, API and packaging components for Regulatory Submissions.
• Manage and provide leadership & guidance to PFS staff in an effective manner consistent with corporate objective.
• Manage training and development of PFS staff.
• Manage group spending within the AS budget in accordance with Supernus policies.
• Interact with other departments (e.g., regulatory, drug delivery sciences, preclinical) and vendors (e.g., API manufacturers) for coordination/management of project activities related to PFS.
• For assigned development projects, manage activities performed by manufacturer(s) for drug substance(s) under development stage, including but not limited to representing PFS in meetings, review of specifications, method development and validation protocols and reports.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Provide assistance for non-assigned development projects if needed.
• Assist with calibration/qualification of laboratory instruments.
• Assist with 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.
• Authorized to legally work in t