Associate Director, Supply Chain

About Principia:

Principia Biopharma is a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology. Principia’s proprietary Tailored Covalency^® platform enables the Company to design and develop reversible and irreversible covalent, small molecule inhibitors with potencies and selectivities that have the potential to rival those of injectable biologics, yet maintain the convenience of a pill. PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 2 clinical trial in patients with immune thrombocytopenic purpura, a rare hematological disease.  PRN2246, a low dose covalent BTK inhibitor which crosses the blood-brain barrier, is being developed for multiple sclerosis and, potentially, for other diseases of the central nervous system.  It has completed dosing in a Phase 1 clinical trial in healthy volunteers and has been partnered to Sanofi. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor, or FGFR, is being evaluated in a Phase 1 trial in patients with solid tumors.

Job Description:

• Reporting to the Director of Supply Chain, this individual will be accountable for the commercial supply chain set up in preparation for product launch and commercialization.  This role is a unique opportunity for an experienced Supply Chain and CMO management leader to shape the supply chain strategy and drive the execution necessary to produce and deliver the company’s first commercial product.  The individual will partner closely with CMC, Quality, Program Leadership and Regulatory and must be able to easily flex from executive level discussions to day-to-day management of commercial supply chain operations; the role is both strategic and hands on. The individual must have the ability to work independently and be an effective team member in a fast-paced environment.

Abilities:

• Develop the strategy for all commercial supply chain activities, including capacity/capability, sourcing, and inventory recommendations
• Oversee supply chain aspects of GMP manufacturing at CMOs, including contracts, purchase orders, production planning, overall performance and tracking of day to day activities
• Lead the commercial packaging and labeling of the product through packaging design, shipping validation, and implementation of artwork; includes GMP oversight and person-in-plant activities for packaging and labeline
• Drive the distribution strategy, 3PL selection, internal serialization set up and oversee the supply chain/distribution networks, including monitoring, tracking and optimizing inventory
• Oversee all import, export, brokerage, storage and transportation for key raw materials, drug substance, drug product and finished goods
• Oversee  state pharmaceutical licensing  program for distribution  
• Support in activities for clinical packaging and labeling, including but not limited to label/package design, primary and secondary packaging, development of IRT specfications, distribution and inventory management
• Review departmental SOPs and ensure updates and compliance with industry standards
• Partner with and develop strong internal collaboration with stakeholders, such as Chemical, Formulation and Analytical Development, Clinical Operations, Regulatory Affairs, Quality, and Project Management functions, to ensure high customer satisfaction
• Contributes to the operational excellence of supply chain management at Principia

Minimum Qualifications:

• At least 5 years of experience in clinical supply management and/or manufacturing functions in the pharmaceutical or medical device industry
• Experience with forecasting, distribution and import/export regulations
• Demonstrated skills in project management and CMO vendor management
• Working knowledge of drug development process and current GXP guidance
• Leadership skills, maturity, composure, emotional intelligence
• Ability to perform in a fast-paced environment with competing priorities under tight deadlines
• Proficient with Microsoft Office (e.g. Project, Word, PowerPoint, Excel, Outlook, Visio)
• Experience within a start-up biotech company a plus
• Bachelor’s Degree required.  Scientific degree preferred.  Advanced degree (Science, MBA) is a plus.
• APICS certification or supply chain education is a plus