Senior Manager/Associate Director, Commercial Supply Operations

Celcuity•Minneapolis, MN

1d•$150,000 - $190,000•Remote

About The Position

The Senior Manager / Associate Director, Commercial Supply Operations, will support the establishment and management of a robust and effective global supply chain to support commercial supply of gedatolisib and future pipeline programs. This position will have a critical role in realizing the vision for Celcuity’s commercial manufacturing organization by supporting the development and maintenance of processes to ensure continuous commercial supply while maintaining regulatory and quality compliance.

Requirements

Bachelor’s degree
8 years’ experience in the pharmaceutical industry with at least 5 years’ work experience in a commercial supply setting preferably in international markets.
Demonstrated experience with oversight of external supply chain partners.
Strong experience with regulatory requirements and inspections for commercial products.
Demonstrated experience with pre-launch and commercial launch activities of a new ethical drug including production planning, system design and implementation.
Proven record of accomplishment in GMP/GDP pharmaceutical or biotech supply chain operations.
New product launch and/or establishment of supply chain for new markets, including selection and integration of new external manufacturing and commercial partners.
Design and deployment of new business processes and supply change management systems (Supply Chain Quality, ERP, S&OP, demand management, etc.).
Strong team leadership and change management experience for routine market supply and market expansion.
Strong quality and compliance background
Work history in a virtual or semi-virtual pharmaceutical company.

Nice To Haves

MBA or other advanced degree focused on Supply Chain Management and/or APICS Certified Supply Chain Professional certification is a plus.
Knowledge of DSCSA requirements is a plus.

Responsibilities

Support production planning, global logistics and warehousing, global supply chain procurement, planning and sourcing, demand management, end-to-end inventory strategy and materials management, global trade compliance, security and integrity and packaging.
Support the development and implementation of the standard business processes, including quality-related activities, to support the launch of new products; business integrations and subsequent supply operations for both internally and at CMO partners.