Manufacturing (cGMP) Production Project Specialist

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

 

Are you interested in joining our team?

Job Summary

The Senior Supply Chain Project Specialist is a key cross-functional facilitator, responsible for driving end-to-end supply chain excellence with a focus on facilitating on-time project execution from order to batch release at the RTP site.

 

This role combines strategic planning, scheduling, sourcing, and wholistic coordination of internal suppliers like Procurement, Logistics, Labs and Client facing teams, Manufacturing, Quality, Technical Services, and Engineering/Maintenance/Validations, to ensure on time execution of batch production through to disposition of the batch.

Acting as facilitator and tracker of all deliverables needed to execute a batch through release of the batch in an efficient manner.

 

This position ensures each project stays on track and coordinates and expedites activities as needed to meet the client and business needs. The role requires exceptional organizational and people management skills, expertise in SAP (MM/IM/WM) or EPR systems, GMP environments, supply chain and project management

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 7:00am - 3:30pm.

Responsibilities

 

 

Planning, Organizing, Cross functional Leadership & Project Management

• Lead and foster a culture of collaboration, accountability and continuous improvement to meet timelines and commitments.
• Serve as a cross-functional facilitator, influencing stakeholders across the organization.
• Promote a culture of on-time execution and delivery, compliance, transparency, and problem-solving.
• Monitor project metrics (On-Time Execution & Delivery & Schedule Adherence), ensuring transparency and timely reporting.

Continuous Improvement & Compliance

• Drive initiatives to improve schedule adherence, reduce costs, and eliminate bottlenecks.
• Support operational excellence and champion continuous improvement efforts by analyzing trends, identifying risks, and implementing corrective actions.
• Collaborates with internal customers and provides a high level of customer service, including recommending solutions, resources, and alternative supply options.
• Ensures and promotes compliance with Company and Procurement policies and procedures.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Batch Readiness & Lifecycle Coordination 

 

• Serve as the primary point of contact for all batch readiness activities—ensuring materials, documentation, and equipment are available and aligned prior to production start.
• Develop and maintain batch readiness trackers to proactively identify gaps or risks that could delay execution or release.
• Coordinate with cross-functional teams (Procurement, QC, Manufacturing, Technical Services, QA, and Logistics) to ensure all pre-batch and post-batch deliverables are completed within committed timelines.
• Partner with Scheduling and Manufacturing teams to ensure accurate alignment of production schedules with material availability, testing capacity, and resource readiness. 

 

Execution Tracking & Issue Resolution 

• Track the progress of each batch from project initiation through final disposition, providing real-time visibility to stakeholders on status, key milestones, and bottlenecks.
• Lead daily or weekly tier meetings focused on batch status, upcoming milestones, and issue escalation.
• Identify and drive resolution of issues impacting timelines, escalating to leadership when necessary to remove barriers.
• Maintain project dashboards, timelines, and key performance indicators (e.g., On-Time Start, On-Time Release, Cycle Time, and Schedule Adherence).

 

Qualifications

• Bachelor’s degree in Supply Chain, Project Management, Operations Management, Engineering, Technical Services, or a scientific discipline preferred.
• 5+ years of experience in project management or supply chain, procurement, or inventory management within pharmaceutical, biotech, or CDMO environments.
• 2+ years leading cross-functional project teams.
• Proven expertise in GMP-regulated environments.
• Experience in CDMO manufacturing environment preferred.4

Knowledge, Skills, and Abilities

• Strong project management and people leadership and collaboration skills; ability to