Senior operations manager Jobs in Boston, MA

Job Description

Biopharma CGT (Cell and Gene Therapies) is seeking a Senior Manager of Materials Operations to lead a team responsible of multiple GMP warehouses within Vertex’s internal Cell and Gene Therapy manufacturing network. This role will be accountable for operations of the Just in Time (JIT) warehouse in the new cell and gene manufacturing facility in Boston’s Seaport district and similar operations in the CAM and VMC (Vertex Manufacturing Center) MFG facility. The Sr Manager also manages the outsource central services function that manages material movement and wipes down into the manufacturing facility. The position will report to the Associate Director of Site Supply Chain.

Key Duties and Responsibilities:

• Act as Business Process Owner for materials operations, collaborating with other Material operations leads within the network, aligning on processes and system needs.
• Responsible for all aspects of warehouse and materials operations functions for the GMP/non-GMP materials within the greater Boston area warehouses from receipt through delivery to the manufacturing floor.
• Develop and oversee execution in compliance with governing regulations, policy and procedures related to storage and transport and delivery of GMP materials to the manufacturing organization.
• Maintain loading dock, GMP warehouse and various staging space, assuming full responsibility for material handling equipment ordering, installation, cleanliness, and maintenance.
• Work with key partners Mfg, PD, AD, QC, QA, Lab Management and others as assigned to ensure compliant processes for all materials operation’s needs.
• Maintain accurate inventory and material controls.
• Own the material flow strategy for CGT LC1 and other facilities as assigned.
• Manage the team that transfers inventory from staging, consumables for GMP cleaning, gowning, and production into the manufacturing suites.
• Oversee outsourced function for central services.
• Manage the flow and staging of incoming raw materials, gowning, cleaning reagents and supplies.
• Own and drive CAPA (Corrective Action and Preventive Action) actions for cleanroom operations improvements and corrections.
• Participate in compliance and EHS audits and own responses/actions.
• Lead MES and MFG batch creation processes, move orders, and all Oracle transactions.
• Other duties and projects as assigned to meet departmental requirements.

Knowledge and Skills:

• College Degree (Bachelor's degree in business, Material Operations Management, or related field) and requires 5 years of experience working within a cGMP material operations environment and/or with GCP regulations.
• Experienced team leader, Self-directed and organized.
• Previous experience in some or all of the following: GMP Manufacturing support, Logistics, Distribution, Warehousing, and Material Operations
• In depth knowledge of warehouse operations in a GMP as well as a non-GMP setting
• Knowledge of warehouse and distribution business processes
• Strong working knowledge of common ERP systems
• Strong knowledge of cGMP requirements for manufacturing
• Excellent communication and problem-solving skills.
• Strong computer skills including Word, Excel, Outlook
• Proficient in aseptic technique in cleanrooms up to Grade A.