Commercial Lead Jobs for OPT Students

INTRODUCTION

Solaris Pharma Corporation is a specialty pharmaceutical company focused on the development and commercialization of high-quality, complex generic and specialty medicines. Backed by deep expertise across the full product development lifecycle and a highly skilled scientific team, Solaris operates with streamlined, efficient processes that reduce development timelines and costs—without compromising quality.

We are dedicated to building a diverse portfolio of complex generics and specialty products, enabling earlier patient access to challenging, high-value therapies. Our strength lies in our integrated capabilities across R&D, regulatory strategy, and commercialization. Solaris’ growing pipeline spans multiple dosage forms, including sterile, dermatological, and solid oral products, each presenting unique formulation, process, regulatory, stability, and scale-up challenges that we are uniquely positioned to solve.

ROLE AND RESPONSIBILITIES

We are seeking a Commercial Operations Lead to join our team in Somerset, NJ. In this role you will support end-to-end Raw material and final product operations for a virtual generic pharmaceutical company operating through contract manufacturing organizations (CMOs) and third-party logistics providers (3PLs).

This role ensures uninterrupted product supply, manages external vendor coordination, and maintains all required state pharmaceutical licenses to support national commercial distribution. The position requires strong cross-functional coordination and the ability to operate effectively in a lean, fast-paced environment with limited internal infrastructure.

This is a high-ownership individual contributor role.

Responsibilities:

• Procurement Execution:

• Request quotes and source APIs, Excipients, primary packaging/container closure and other materials for projects.

• Order RLD, generic products, chemicals and general lab supplies (such as basic gloves and laboratory instruments).
• Maintain weekly inventories for all supplies and supply planning trackers to prevent stockouts or excess inventory. Re-ordering as needed.
• Coordinate material requirements and purchase orders with CMOs and key raw material suppliers.
• Track material lead times, CMO production schedules, and monitor batch status to ensure alignment with forecast.
• Manage customs clearance and other import requirements when needed.
• Establish CDA with new vendors and maintain records.
• Escalate supply risks proactively and support mitigation planning.

• Secure and maintain Regulatory/QA requested documents/statements.

• Supply Chain Coordination:

• Support demand forecasting and monthly supply review processes.

• Monitor finished goods inventory at 3PL locations.
• Track safety stock levels and expiration dating across the network.
• Coordinate inbound and outbound shipments with 3PL partners.
• Monitor backorders and customer/CMO service level performance.
• Prepare supply chain performance reports for leadership.

• Assist with reviewing supply agreements and support pricing analysis.

• State Licensing & Regulatory Support

• Maintain all required state licenses by preparing and submitting new state license applications and renewals for:

  • Manufacturer (virtual)
  • Wholesaler/Distributor
  • Controlled substance registrations (if applicable)
• Track and manage renewal deadlines to ensure zero lapses.
• Serve as administrative point of contact for State Boards of Pharmacy.
• Maintain FDA establishment registration and related documentation.
• Coordinate with 3PL and CMO partners to ensure alignment of licensure where required.

• Maintain organized licensing files to ensure audit readiness.

• DSCSA & Distribution Compliance

• Support serialization and track-and-trace compliance across 3PL partners and customers.

• Maintain trading partner documentation and authorized trading partner verification.

• Assist with documentation requests related to distribution audits.

• Cross-Functional and Lean Operations Support:

• Partner with Quality on supplier documentation and CMO coordination.

• Support Regulatory Affairs during product launches and new market entries.
• Assist Finance with accrual tracking, inventory reporting, and cost monitoring.
• Participate in supply risk assessments and business continuity planning.
• Contribute to process improvements appropriate for a lean organization.
• Interact daily with Analytical scientists, Formulation scientists, Project Management, and Commercial Operations for details on order status and other assigned tasks.

BASIC QUALIFICATIONS

• Bachelor’s degree in supply chain, Business, Life Sciences, or related field required. Will consider an equivalent combination of relevant education and experience.
• Minimum two (2) years of experience in pharmaceutical procurement, supply chain, or regulatory operations.
• Experience in pharmaceutical manufacturing is preferred.
• Familiarity with FDA, cGMP, and DSCSA requirements preferred.
• Experience supporting state pharmaceutical licensing processes strongly preferred.
• Highly organized with strong deadline management.
• Comfortable working in fast-moving environments.

COMPENSATION

• Pay: $65,000.00 - $85,000.00 per year

BENEFITS

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

LOCATION

Work Location: In person