Senior Manager Supply Chain Planning

Bluerock Therapeutics - Cambridge, MA

Full-time - Senior

Cambridge, MA

Professional, Scientific, and Technical Services

About the position

The Senior Manager of Supply Chain Planning at BlueRock Therapeutics plays a pivotal role in overseeing both strategic and tactical planning operations within the organization. This position is integral to leading cross-functional continuous improvement initiatives and risk mitigation efforts that support all research, development, and clinical GMP manufacturing teams at BlueRock. Reporting directly to the Director of Supply Chain, the Senior Manager is tasked with developing comprehensive planning scenarios that align with the company's goals, ensuring that supply chain operations are efficient and effective in meeting the demands of CMC development and clinical objectives. In this role, the Senior Manager will be responsible for the business lead in supply chain system implementation, establishing key inventory metrics, and procuring essential raw materials. The position also involves developing sourcing strategies and addressing supply and quality risks associated with critical raw materials in collaboration with suppliers. The Senior Manager will continuously drive best practices in scheduling, capacity modeling, and the D&OP process, while also enhancing internal communication through a well-defined responsibilities framework. The responsibilities extend to managing and streamlining procurement and purchasing activities across all BlueRock sites, ensuring a seamless continuity of supply for research, development, and clinical manufacturing. The Senior Manager will lead cross-functional teams to address and remediate supply and quality risks, representing the Supply Chain function in CMC governance programs from concept through to phase 3 stage gate deliverables. Furthermore, the role includes the development and implementation of supply chain planning standards, encompassing planning and scheduling, safety stock policies, inventory and risk management, and internal data collection. As a Subject Matter Expert (SME) for systems implementation related to inventory, sourcing, and logistics, the Senior Manager will also participate in vendor qualifications, quality agreements, and audits/inspections, ensuring that all operational documentation aligns with BlueRock's GMP Quality System.

Responsibilities

• Develop and manage a BlueRock-wide integrated planning process that aligns demand, supply, and resources to meet CMC development and clinical goals.
• Manage and streamline procurement/purchasing activities for all BlueRock sites ensuring continuity of supply for all research, development, and clinical manufacturing.
• Lead cross-functional teams to remediate supply and quality risks of critical raw materials with suppliers for ongoing and upcoming CMC programs/platforms in the BlueRock pipeline.
• Lead and represent Supply Chain in the CMC governance cross-functional programs from concept to phase 3 stage gate deliverables.
• 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.
• 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.

Requirements

• Minimum of a Bachelor's degree in scientific discipline or related field is required.
• Minimum of 13 years of related or equivalent work experience in supply chain or technical operations role is required.
• Minimum of 3 years of relevant planning and/or project leadership experience is required.
• Direct experience with implementing business processes, Oracle/SAP, production planning, 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 in working with electronic systems such as ERP, LIMS, CMMS, WMS is required.
• Ability to analyze and resolve problems independently.

Nice-to-haves

• General understanding of pharmaceutical supply chain including serialization is preferred.
• Demonstrated application of quality and efficiency improvement methods such as LEAN, Six Sigma is preferred.