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.

Job Summary:

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

Essential Duties & Responsibilities:

• Provides science based technical expertise and leadership to the Technical Operations (TechOps) department in the areas of product and process development, process validation, equipment qualification and commercial manufacturing.
• Provides supervision to the TechOps 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 TechOps 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 TechOps group and/or department head as required.
• Ensures the TechOps department complies with current SOPs, Safety and Environmental Regulations and GMPs.
• Other duties as assigned.

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:

• 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 functional teams.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have 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, when not working in the lab. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time.
• When in the lab, employees will be required to exert up to approximately 50 pounds of force occasionally and/or up to 30 pounds of force frequently, as well as exerting up to 10 pounds of force constantly to move objects, when working in the lab.
• The employee is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is also required to have the visual acuity to perform activities such as operating machines, and to perform mechanical or skilled trade tasks of a non-repetitive nature.
• Will be required to work in a clean processing room environment occasionally and wear personal protective equipment to include but not limited to gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits occasionally.
• The employee is not substantially exposed to adverse environmental conditions on a regular basis. Employees may have to wear Tyvek suits when working in the lab, which can make conditions warmer, and more challenging. Employees will be required to work and exert force while wearing Tyvek suits.
• Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, kneeling, crouching, walking and pushing.
• Occasional Domestic and International travel.

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 $190,000 to $229,000. 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.

You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age, or any other characteristic protected by law.