The Director, Supply Chain CSI CMC is accountable to lead cross-functional workstreams and teams focused on all of the activities in achieving the delivery of cell suspension for injection (CSI) / Dose for Administration (DfA) to the surgical centers involved with our clinical trials. This includes working along with Demand and Supply Planning and CSI Delivery among other peer teams such as QA, QC, Manufacturing, CMC teams (and leads) and Operation’s Management to build and manage the storage, transportation and processing of drug product, formulation raw materials and consumables, from vendors, through 3PLs and finally getting the CSI/DfA to the Operating room on the day of surgery.
Reporting into the Head of Operations, this role supports all BlueRock Tech Ops and Clin Ops/Dev functions and connects these activities cross-functionally to our CMC/Device teams and CMC Strategy leads as well as SC Planning and Finance. Work may include procuring raw materials, developing sourcing strategies, and remediating supply and quality risks, drives best practices such as scheduling, capacity modeling, Development & Operations Planning process, and internal communication with responsibilities framework.
While directly the immediate delivery of clinical DP and CSI/DfA to the current clinical programs, the position will also need to look forward to build collaboratively and transfer a commercializable CSI supply chain to Bayer/Berkeley for commercial delivery. This will require travel to multiple locations, including Berkeley California, to collaborate with Bayer Supply Chain colleagues in the design and transfer of a functioning CSI logistics network that becomes a commercially scalable system to Bayer. Travel may be at times up to 25% of any quarter.
Responsibilities:
- Lead cross functional teams to build or remediate supply and quality risks for ongoing and upcoming CMC programs/platforms in the BlueRock pipeline
- Manage the shipment of products and samples in the required configurations with permits and documentation to successfully deliver product to clinics, samples to contract test labs.
- Support in the development of cold chain and ambient temperature distribution plans of drug product, formulations, and devices to participating clinics in North America, EU, and Asia for BlueRock Therapeutics platforms in the clinical stage
- Work with other Supply Chain teams as needed to develop and manage integrated planning processes to meet CMC development and clinical goals
- Build strategic relationships with both new and existing vendors enabling quality and scalable supply of raw materials
- Lead and represent Supply Chain in the CMC governance cross functional programs from concept to phase 3 stage gate deliverables
- Potentially with other stakeholders, develop and implement supply chain planning standards including, planning/scheduling, safety stock policies, inventory and risk management, and internal data collection
- Act as SME for systems implementation pertaining to inventory, sourcing, and logistics
- Lead a comprehensive GMP materials management system and strategy for the site including the supporting policies and procedures, quality systems and master data
- Participate and support in vendor qualifications, quality agreements and audits/inspections.
- Manage any operational documentation or data returned from clinical sites to incorporate into BlueRock GMP Quality System.
- Ensure metrics are tracked/reported as needed.
- Ensure all tasks are completed in a safe and compliant manner considering relevant BlueRock procedures/policies, regulatory guidance, and current practices (GMPs) for all aspects of Supply Chain and Logistics.
Minimum Requirements:
- BS/MS or PhD in a business or scientific field with ≥12+ years of experience of related or equivalent work experience in operation, procurement or supply chain role is required
- Minimum of 5 years of relevant supply chain management and/or project leadership experience is required
- Direct experience with shipments requiring critical/ultra-cold chain constraints, materials, inventory control and warehousing & distribution is required.
- General understanding of pharmaceutical supply chain including serialization is preferred.
- Experience working in GxP pharmaceutical and/or biotechnology regulated environment is required.
- Experience in representing the function as Subject Matter Expert (SME) and defending GxP systems in audit setting is required.
- Highly functional in a fast-paced, dynamic company with ability to adapt to changing timelines and priorities required.
- Excellent written and verbal communication skills are a must.
- Experience with relevant legal standards and compliance systems is required
- Working knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards is required
- Demonstrated application of quality and efficiency improvement methods such as LEAN, Six Sigma is preferred.
- Experience working with contract service providers such as offsite warehouse and logistics is required.
- Experience in working with electronic systems such as ERP, LIMS, CMMS, WMS is required.
- Ability to analyze and resolve problems independently.
Working Environment:
- You may, on occasion, be asked to lift 20kg and/or work with a partner to lift anything heavier.
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