Director, Supply Chain CSI CMC

BlueRock Therapeutics; Halifax Regional Municipality; On-site; CAD 80,000 - 130,000; Full time

Job summary

An innovative firm is seeking a Director of Supply Chain to lead cross-functional teams in delivering essential clinical products. This pivotal role involves managing logistics, developing strategic vendor relationships, and ensuring compliance with regulatory standards. With a focus on both immediate delivery and scalable supply chain planning, you'll play a crucial part in connecting operations with clinical development. The position offers opportunities for travel and collaboration with global teams, making it ideal for a seasoned professional looking to make a significant impact in the pharmaceutical industry.

Qualifications

• 12+ years of related experience in supply chain management.
• Experience with critical/ultra-cold chain shipments and inventory control.

Responsibilities

• Lead cross-functional teams to address supply and quality risks.
• Manage shipment logistics for clinical products and samples.
• Develop distribution plans for cold chain delivery across multiple regions.

Skills

Supply Chain Management

Project Leadership

Communication Skills

Problem-Solving Skills

GxP Compliance

LEAN

Six Sigma

Education

BS/MS or PhD in a relevant field

Tools

ERP Systems

LIMS

CMMS

WMS Systems

Job description

Role Overview

The Director, Supply Chain CSI CMC is responsible for leading cross-functional teams to ensure the delivery of cell suspension for injection (CSI) and Dose for Administration (DfA) to surgical centers involved in clinical trials. This includes coordinating with Demand and Supply Planning, CSI Delivery, QA, QC, Manufacturing, CMC teams, and Operations Management to manage storage, transportation, and processing of drug products, raw materials, and consumables from vendors through 3PLs to the operating room.

Reporting to the Head of Operations, this role supports BlueRock Tech Ops and Clinical Operations/Development functions, connecting these activities with CMC/Device teams, CMC Strategy leads, SC Planning, and Finance. Responsibilities may include raw material procurement, sourcing strategies, risk remediation, scheduling, capacity modeling, development & operations planning, and internal communication frameworks.

The position primarily focuses on the immediate delivery of clinical drug product and CSI/DfA but also involves planning for a scalable commercial supply chain transfer to Bayer/Berkeley, including travel to Berkeley, CA, up to 25% of the time.

Responsibilities

• Lead cross-functional teams to address supply and quality risks for current and future CMC programs.
• Manage shipment logistics, including permits and documentation, for clinical products and samples.
• Develop distribution plans for cold chain and ambient temperature delivery across North America, EU, and Asia.
• Collaborate with Supply Chain teams to align planning processes with development and clinical goals.
• Establish strategic vendor relationships to ensure quality and scalable raw material supply.
• Represent Supply Chain in CMC governance programs from concept to phase 3.
• Develop and implement supply chain planning standards and policies.
• Serve as SME for inventory, sourcing, and logistics systems.
• Lead GMP materials management systems, policies, procedures, and master data management.
• Participate in vendor qualification, quality agreements, and audits.
• Manage operational documentation from clinical sites for GMP compliance.
• Track and report relevant metrics.
• Ensure all activities comply with safety, GMP, and regulatory standards.

Minimum Requirements

• BS/MS or PhD in a relevant field with 12+ years of related experience.
• At least 5 years of supply chain management or project leadership experience.
• Experience with critical/ultra-cold chain shipments, inventory control, and distribution.
• Understanding of pharmaceutical supply chain, serialization preferred.
• Experience in GxP regulated environments and defending GxP systems in audits.
• Ability to adapt in a fast-paced, dynamic setting.
• Excellent communication skills.
• Knowledge of legal standards, compliance, QA, and EHS standards.
• Experience with LEAN, Six Sigma is a plus.
• Experience working with contract logistics providers.
• Proficiency with ERP, LIMS, CMMS, WMS systems.
• Strong problem-solving skills.

Working Environment

• Occasional lifting of up to 20kg, potentially with assistance.