SeniorProject Manager

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented team.

Senior Project Manager

New Albany, Ohio

• The ideal candidate will be a highly experienced Project Manager with a strong background in biotech or pharmaceutical manufacturing, specifically supporting new product introductions (NPI) and facility expansions.
• They should have a minimum of a bachelor's degree in science, engineering, or management and at least 7 years of relevant experience (15 years preferred). The candidate must demonstrate hands‑on experience managing end‑to‑end project schedules, coordinating across cross‑functional stakeholders including Process Development, Capital Projects, and Supply Chain.
• Strong knowledge and experience with Smartsheet, NPI variations, and Change Control generation, implementation, and closeout are required.
• Strong communication, organizational, and risk mitigation skills are essential. This role requires full onsite presence in New Albany, OH, with occasional extended hours during peak project phases.

• Leading the NPI's for necessary process, facility, equipment, materials, and training modifications.
• Development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities.
• Change control management.
• Manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities.
• Engage with network partners to develop process and technology strategies that achieve clinical/commercial development schedules while minimizing transfer risks.
• Facilitate the development and optimization of NPI business processes.
• Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI.
• Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications).
• Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

• Bachelor's degree in science, engineering, or management and at least 7 years of relevant experience (15 years preferred).
• Previous managerial experience directly managing people and/or leading teams, projects, programs, or directing the allocation of resources.

• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross-functional teams.
• Collaborate and communicate with higher-level outside resources.
• Skill, knowledge, and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
• Strong communication (both written and oral), facilitation, and presentation skills.
• Strong skill in working independently and effectively interacting with various levels.
• Ability to lead and influence staff outside own organization.
• Ability to motivate staff and manage and distribute workloads.
• Able to manage performance issues and conflict.
• Ability to provide direction and establish goals for individual staff members and work groups.
• Ability to evaluate documentation/operations according to company and regulatory guidelines.
• Ability to interact with regulatory agencies.
• Demonstrate the Values/Leadership Practices.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.