Supernus Pharmaceuticals, Inc. · 3 days ago
Director, Technical Operations
Rockville, MD
Full-time
Onsite
Director/Executive
$190K/yr - $229K/yr
8+ years expSupernus Pharmaceuticals is an award-winning biopharmaceutical company with over 30 years of experience in developing products for CNS diseases. The Director of Technical Operations will provide scientific and technical leadership for the Technical Operations team, overseeing product and process development, technology transfer, validation, and commercial manufacturing activities while ensuring compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
No H1B
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
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
Qualification
Required
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
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
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
Authorized to legally work in the United States without visa sponsorship
Preferred
At least five years of supervisory experience desired
Biopharmaceutical, biotechnology products development and manufacturing, and parenteral products development and manufacturing experience is desired
Benefits
Health
Dental
Vision
Paid time off
401k company match
Company paid life insurance
Health and wellness benefits
Stock equity awards
Employee stock purchase programs
Participation in our Company’s discretionary annual bonus program
Company
Supernus Pharmaceuticals, Inc.
We are a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$689.5MKey Investors
UBSNew Enterprise Associates
2023-02-14Post Ipo Debt· $150M
2018-03-13Post Ipo Debt· $350M
2013-04-24Post Ipo Debt· $90M
Leadership Team
J
Jack A. Khattar
President & CEO
F
Frank Mottola
Chief Technical Operations Officer
Recent News
2025-12-08
Company data provided by crunchbase