Senior Specialist, Supply Chain
BlueRock Therapeutics, LLC
Toronto, Ontario, Canada
2d ago

Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique CELL+GENE™ platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel CELL+GENE™ platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas : neurology, cardiology, and immunology.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases.

We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

Description of Position :

BlueRock Therapeutics is seeking an experienced Senior Specialist, GMP Supply Chain who will report to the Senior Director of GMP Manufacturing.

This individual will support the Toronto GMP manufacturing pilot plant facility and have accountability for all material functions including managing production planning and inventory control across facilities, GMP procurement and receiving, QC lab supply ordering and inventory, product and sample shipment, shipping and component validation, facility logistics and support for tech transfers.

The Senior Specialist is a subject matter expert in developing the needed internal business processes such as GMP material specifications, raw material process flows, shipping and receiving, shipping components.

In addition, the position will work closely with the other Toronto GMP teams and management in support of meeting GMP readiness timelines and goals for the facility and tech transfers.

Responsibilities :

  • Ship products and samples in the required configurations with permits and documentation to successfully deliver product to clinics, samples to contract test labs.
  • Lead a comprehensive GMP materials management system and strategy for the site including the supporting policies and procedures, quality systems and master data
  • Develop cold chain and validation plans to transfer and distribute of cold chain drug product to participated clinics in North America from BlueRock Therapeutics
  • Ensure all daily tasks across the supply chain business processes are completely accurately to SOP and in a timely and safe manner with required GMP documentation.
  • Ensure import / export compliance and regulations are followed while managing external brokers and vendors.
  • Participate in vendor qualifications, quality agreements and audits / inspections.
  • Maintain supply chain and inventory controls to ensure uninterrupted manufacturing operations and QC lab operations, manage warehouse and equipment / product alarm response for related equipment.
  • Partner with suppliers to create a flow process of materials into the warehouse, driving efficiency and effectiveness of receiving and inventory storage.
  • Develop and execute shipping validation including designing the validation program, shipping component and lane selection and confirmation to ensure product security and quality are maintained in specified conditions.
  • Ship products and samples in the required configurations with permits and documentation to successfully deliver product to clinics, samples to contract test labs.
  • Maintain the secure and compliant storage and control of raw materials, process intermediates and final product in the required conditions.
  • Manage any operational documentation or data returned from clinical sites to incorporate into BlueRock GMP Quality System.
  • Coordinate internally for product returns and complaints resolution.
  • Ensure that appropriate training & certification of all GMP warehouse personnel on equipment, process and facility safety procedures is maintained and up-to-date.
  • As needed, partner with BlueRock Lab Operations and building / site management to support the whole BlueRock site’s logistics needs.
  • Ensure metrics are tracked / reported as needed.
  • Ensure compliance with all BlueRock procedures and policies as well as regulatory guidance and current practices (GMPs) for all aspects of Supply Chain and Logistics.
  • Minimum Requirements :

  • Minimum of a Bachelor’s degree in scientific discipline or related field is required.
  • Minimum of 8 years of related or equivalent work experience in a materials specialist or supply chain role 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
  • Equal Opportunity Workplace : At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace.

    Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

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