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?

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

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

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).

• 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

• Strong project management and people leadership and collaboration skills; ability to influence without direct authority.
• Advanced SAP (or equivalent) knowledge and proficiency with Planning, inventory control, and Materials Management processes.
• Strong collaboration and internal supplier management skills across the network.
• Excellent communication and presentation skills, with the ability to interact with senior leaders, internal stake holders, clients, and cross-functional teams.
• Proficiency in MS Office Suite, Smartsheet, Salesforce, and electronic document management systems.
• Strong business acumen with the ability to track timelines and commitments for all projects project and financials to budget and forecast for revenue.
• Strong sense of urgency and attention to detail.
• Drives performance. Holds self and others accountable.
• Excellent organization, communication and follow-up skills.
• Ability to self-direct and take constructive action in ambiguous situations.
• Extremely high standards of excellence.
• Analytical with a methodical approach to problem solving.
• Ability to handle multiple and sometimes competing priorities.

• Up to 20% travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.