Supernus Pharmaceuticals, Inc. · 2 days ago
Senior Process Engineer, Technical Operations
Rockville, MD
Full-time
Onsite
Mid, Senior Level
$105K/yr - $127K/yr
6+ years expSupernus 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. The Senior Process Engineer is responsible for supporting the Technical Operations department through process development, optimization, and technology transfer activities, including leading manufacturing process development and mentoring junior personnel.
BiotechnologyHealth CarePharmaceutical
No H1B
Responsibilities
Lead and support dosage form manufacturing process development activities in compliance with applicable GMP requirements
Serves as the Subject Matter Expert for technical and technology transfer activities to Contract Manufacturing Organizations (CMOs)
Participate in process validation activities, including the review of validation protocols and reports
Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques, and production yields for existing products
Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) targeting physical cause of failure
Works cross-functionally with Quality Assurance and GMP Operations to lead the manufacture of Clinical Trial Materials (CTM)
Writes equipment SOP’s, study protocols, technical reports, and equipment qualification documents
Demonstrates technical proficiency across a broad range of manufacturing equipment and processes
Prepares appropriate sections of regulatory submission documents, including INDs, NDAs, Briefing packages, IMPD, CTA, and related items
Mentors and/or supervise junior personnel in equipment use and manufacturing process development
Other duties as assigned
Qualification
Required
Bachelor of Science with a minimum of six years of relevant industry experience in manufacturing, process development, scale-up, technology transfer and process validations
Masters in Pharmaceutics, Chemical engineering, or related field. or equivalent combination of education and experience with four years' relevant pharmaceutical or GMP experience
Ph.D. in a relevant subject and zero years of experience
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
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