Note: The job is a remote job and is open to candidates in USA. Aequor is seeking a Project Manager to lead peptide drug substance technology transfer and new product introduction programs. The role coordinates cross-functional teams and CDMO partners, manages project plans and milestones, oversees quality and change-control activities, and supports contract, procurement, and site performance management.
Responsibilities
- Lead complex peptide drug substance manufacturing new product introduction technology transfer activities for new launches or programs tech transferring into CDMO programs from development through commercial implementation
- Serve as the primary program lead coordinating with Process Development, Quality, Regulatory, Supply Chain, Validation, Engineering, Procurement, and Contract Manufacturing Organizations (CMOs/CDMOs)
- Develop and execute comprehensive technology transfer strategies, plans, schedules, and governance frameworks
- Drive stage-gate deliverables and ensure alignment with program milestones, budgets, and business objectives
- Facilitate issue resolution and rapid decision-making to maintain project timelines
- Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; contract inputs and requirements, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc
- Own Deviations (Major/Minor). Maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per the company's quality standards and procedures. Optimize deviation management, corrective and preventive actions effectiveness to prevent reoccurring events
- Own SICAR, CAPA, CAPA EV and more complex change control records
- Report contract site performance metrics to site lead, identify improvement opportunities for site performance, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT)
- Oversight and reporting of procurement/payment of invoices
Benefits
- Remote work arrangement
Company Overview