Senior Manager, Commercial Supply Chain

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSTION SUMMARY 

Manage Mirum’s end-to-end commercial supply planning activities for global markets. The successful candidate will demonstrate end-to-end commercial supply chain expertise (including global artwork and labeling & packaging end-to-end process and systems), be able to work independently and enjoy working in a dynamic, complex, fast-paced environment during a period of significant growth and global expansion.

This is a highly integrated role that will work cross-functionally partnering with Mirum’s internal functions/SMEs and external partners to ensure supply continuity.

JOB FUNCTIONS/RESPONSIBILITIES

• Manage the end-to-end commercial supply planning and scheduling with Mirum’s CMOs and CPOs (including managing raw materials, material allocations based on jurisdictional control requirements).
• Own the planning process to ensure supply continuity managing active replenishments to support the future sales forecast while minimizing inventory costs and effectively communicating supply needs within Mirum and to CMOs and CPOs.
• Own the artwork management process to develop pristine and compliant artwork aligned with approved global labeling and adhering to regulations across the worldwide health authorities/agencies.
• Partner with Senior Director Commercial Supply Chain to continuously optimize the Global S&OP process. Manage the Global Supply Review (GSR) process specifically ensuring no impact to global supply, closely managing routine manufacturing for API & Drug Product & Packaging.
• Partner closely with the CMC, Regulatory, and Quality teams to ensure smooth transition from process validation to routine commercial manufacturing. Ensure that CMC is a partner during routine manufacturing to cover all technical manufacturing requirements.
• Partner with the Supply Chain BPO for the set-up and management of commercial supply chain systems and processes – ensure all elements of drug substance allocation, drug product management, jurisdictional control restrictions, etc. are incorporated in the attributes and master data in Rapid Response Advance Planning System.
• Support new products and product life cycle management improvements projects as required.
• Partner with the Supply Chain BPO to draft, formalize and maintain commercial SOPs for manufacturing, jurisdictional control, planning, artwork management etc, as required.
• Manage and lead supply chain projects & initiatives with artwork, manufacturing and distribution to improve supply flow, inventory costs, and business processes.
• Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
• Support labeling inspection/audit readiness activities
• Keep abreast of any changes in regulatory requirements that may impact Mirum’s end-to-end manufacturing planning and distribution.

 QUALIFICATIONS

 Education/Experience:

• A./B.S. required.
• 6+ years of global supply chain or supply chain planning related experiences (including S&OP) in Pharmaceutical / Biotech operations.
• Experience in working with CMOs, CPOs, 3PLs, vendor and artwork management.
• Proven understanding of global pharmaceutical distribution requirements (including cold chain) and trade compliance
• Experience in end-to-end supply chain network, forecasting, inventory management, safety stocks, jurisdictional control and artwork management.
• Advance planning system experience preferred, i.e., Rapid Response
• Certification in ASCM CPIM preferred.
• Demonstration of project management, negotiation, and excellent communication skills or new product supply chain planning experience preferred.

Knowledge, Skills and Abilities:

• Proven ability to manage end-to-end supply planning in a virtual manufacturing environment working with CMOs and CPOs
• Demonstrates a ‘can-do, agile’ attitude and willing to work in a small, dynamic environment.
• Proactive, shows good judgement, anticipates future consequences, and can make decisions decisively in the face of ambiguity.
• Demonstrates understanding of labeling requirements, regulations, and guidance in support of labeling strategies worldwide.