Senior Manager/Associate Director, Commercial Supply Operations

Linn Products, Inc; Minneapolis (MN); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

PTO

Paid holidays

Annual performance incentive bonus

New hire equity package

Job summary

Celcuity is seeking a Senior Manager / Associate Director, Commercial Supply Operations to establish and manage a robust global supply chain for commercial Gedatolisib and future programs. The role supports development of processes ensuring continuous commercial supply while maintaining regulatory and quality compliance.

The position will oversee production planning, logistics, warehousing, procurement, demand management, and end-to-end inventory strategy, including compliance with DSCSA and

Qualifications

• Bachelor's degree required; MBA or advanced SCM degree a plus.
• 8 years in the pharmaceutical industry with 5+ years in commercial supply, international markets preferred.
• Experience overseeing external supply chain partners.
• Strong regulatory requirements knowledge and inspections for commercial products.
• Experience with pre-launch and commercial launch activities of a new product, including production planning and system design.

Responsibilities

• Support production planning, global logistics, warehousing, procurement, planning and sourcing, demand management, inventory strategy and materials management.
• Develop and implement standard business processes, including quality activities, to support launches and CMOs.
• Support launches with external partners and supply operations for internal and external sites.
• Ensure regulatory compliance and maintain supply continuity across markets.

Skills

Leadership

Communication skills

Time management

Teamwork

Adaptability

Relationship building

Regulatory knowledge

GMP/GDP knowledge

Education

Bachelor's degree

MBA or related advanced degree

APICS CSP certification

Tools

ERP systems

S&OP software

Quality management systems

Job description

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.

Responsibilities

This role will 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. This role will also 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.

Competencies

• Leadership and interpersonal skills, including a collaborative and team-oriented approach.


• Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.


• Good organizational, time management and computer and software skills.


• Flexible, able to learn and implement new techniques, technologies, and novel approaches.


• Ability to quickly react to and mitigate unforeseen challenges.


• Ability to build strong relationships with co-workers of various backgrounds and expertise.


• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.

Experience

• Bachelor's degree; MBA or other advanced degree focused on Supply Chain Management and/or APICS Certified Supply Chain Professional certification is a plus.


• 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.


• Knowledge of DSCSA requirements is a plus.


• 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.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $150,000 - $190,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.

Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

• annual performance incentive bonus


• new hire equity package


• medical


• dental


• vision insurance


• 401(k) match


• PTO


• paid holidays

About Us

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.