Job Title: Sr. Project Manager
Industry: Biotechnology Manufacturing
Location: New Albany, OH 43062
Schedule: Monday-Friday 8:00am-5:00pm
Pay: $66/hr + Benefits: Med/Den/Vis, 401k

Job Description:

• Work with various NPI support groups to develop, maintain, and execute the NPI project plan which includes NPI scope, schedule, resources, and risk management
• Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks.
• 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
• Responsible for hiring, training, supervising, and performance management of staff
• 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
• Review and approve product MPs, process validation protocols and reports for manufacturing processes, change-over completion, and Environmental Characterization reports and planned incidents
• Represent QA on NPI team. Lead investigations and plant audits, participate in site audits

Experience Requirements:

• Strong Project Management, organizational skills including ability to follow assignments through completion and initiate/lead cross-functional teams
• Experience with manufacturing and distribution processes, including QA, QAL, validation, and process development
• Strong communication, facilitation, and presentation skills
• Ability to lead and influence staff outside own organization, provide direction and establish goals for staff members, and manage performance issues & conflict
• Experience and ability to interact with regulatory agencies

Please refer the Job description for details