Elemental Enzymes

Project Manager

• Manage and develop relationships with strategic external contract manufacturer relationships, acting as single-point owner and understanding their capabilities and capacities
• Identify and onboard new external contract manufacturer relationships and establish technology transfer and manufacturing product transfer plans with contract manufacturers.
• Act as Project Manager to the production process, maintaining consistent communication throughout the production process with internal and external stakeholders, including all components of the production, timelines, deliverables, and key metrics.
• Execute the manufacturing plan with assigned external partners (Providing forecasts, issuing Purchase Orders, processing Work Orders, and vetting invoices for payment).
• Responsible for batch performance regarding process accuracy, quality, costs, batch metrics, and ERP accuracy.
• Conduct thorough batch record review to ensure process compliance and production performance.
• Manage deviations and establish corrections and preventative actions (CAPAs) in collaboration with Quality Manager and external partners.
• Performs proper problem-solving techniques to identify root causes to deviations.
• Performs Plan, Do, Check, Act (PDCA), methods to ensure effective preventative actions are implemented.
• Negotiate sensitive issues with external partners, gathering feedback from all internal stakeholders to ensure optimal outcomes.
• Collaborate with Product Development to perform technology transfers at contract manufacturers ensuring right, first time, technology transfer with support of process development team.
• Implementation of established R&D-designed processes and active participation in process development as required during PD transition to manufacturing.
• Thoroughly document and maintain detailed records of the production process, from planning to product delivery, sufficient for Scorecarding Process, aimed at product and partner performance improvements.
• Provide scientific technical support for technology transfer of processes to manufacturing on and offsite.
• Develop in-depth knowledge of external partners capabilities and capacities to best understand production timelines, Learn operations of new equipment and procedures to support the growth requirements of the company.
• Participate in writing and/or supporting existing SOPs for manufacturing operations.
• Audit CMOs when necessary to ensure they are in compliance with process protocols.
• Create, monitor, and improve performance metrics (KPIs) to manage external contractors.
• Proactively identify and solve process improvements while maintaining a full workload.
• Support internal manufacturing process engineering when necessary.
• Other duties as assigned.
• The roles and responsibilities for this function may change depending on business needs.

Contract Manufacturing Project Manager