Director, Technical Operations

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.

The Director of Technical Operations is responsible for providing scientific and technical leadership for the Technical Operations team. This role will oversee product and process development, technology transfer, validation, and commercial manufacturing activities. This position is responsible for managing internal and external manufacturing operations ensuring compliance with Current Good Manufacturing Processes (cGMP) and regulatory standards. This role is also responsible for collaborating cross‑functionally with Commercial, Regulatory, Corporate Development, and external partners.

• Provides science based technical expertise and leadership to the Technical Operations (Tech Ops) department in the areas of product and process development, process validation, equipment qualification and commercial manufacturing.
• Provides supervision to the Tech Ops department in the manufacture and packaging of commercial products, cGMP clinical supplies, on‑site and/or at contract manufacturing organizations.
• Provides technical expertise and supervision in drug product technology transfer and scale up, registration, pre‑validation, and validation activities at contract manufacturing organizations.
• Collaborate with the Commercial teams in defining drug product trade dress and commercial packaging.
• Supports the drug product regulatory process by writing and reviewing sections of CTDs for INDs, CTAs and NDA submissions, amendments, and yearly updates.
• Contributes to briefing packages and represents the Tech Ops department as needed at CMC related FDA meetings.
• Supports the Corporate Development department evaluating drug product opportunities.
• Supports the Company's intellectual property activities.
• Reviews and approves specifications, master batch records, SOPs, product development protocols and technical reports.
• Contributes to the yearly departmental operating budget, head count and equipment needs based on the approved project objectives.
• Assists with the contract bid quotation and award process for departmental projects at third party organizations.
• Participates in project teams as a team member or leader as needed.
• Regularly communicates progress of projects to the Tech Ops group and/or department head as required.
• Ensures the Tech Ops department complies with current SOPs, Safety and Environmental Regulations and GMPs.
• Other duties as assigned.

• 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.

• Ph.D. and Minimum of eight years of relevant pharmaceutical and/or GMP experience, or a Master's with ten years of relevant pharmaceutical and/or GMP experience, or equivalent combination of education and experience.
• At least five years of supervisory experience desired.
• Must have proven track record in the drug development process, manufacture of clinical and commercial supplies and drug product technology transfer and scale up / manufacturing.
• Biopharmaceutical, biotechnology products development and manufacturing, and parenteral products development and manufacturing experience is desired.
• Must have proven track record in cGMP regulations and quality systems.
• Previous experience in analyzing and interpreting scientific, technical, and regulatory documents.
• Previous experience responding to complex inquiries or complaints from customers or regulatory agencies.
• Demonstrated technical, interpersonal, communication and leadership skills and the ability to work on cross…