Project Manager – Operational Excellence

Role Overview

• Develop and manage project schedules to track key milestones and project completion
• Track a project through all phase gates of project initiation, planning, implementation, and closure
• Manage resource allocation and project prioritization of key projects
• Generate Risk Mitigation Plans and Risk Register for medium to large projects to ensure successful project completion
• Generate Project Plans for large projects to summarize project scope, qualification strategy, submission strategy and timeline.
• Lead and manage medium to large plant projects that impact capacity expansion, reliability, process improvement, and quality/compliance.
• Generate Risk Assessments for implementation of projects prior to closure of change control
• Coordinate on-time project implementation with supporting groups such as Manufacturing, Quality Assurance, Facilities, Maintenance, Validation, Quality Control, Quality Operations, and Materials Management.
• Coordinate change control approval and implementation of projects; track projects through change control to closure
• Be curious to ask probing questions to ensure team's understanding of project objectives and requirements, facilitate discussions to clarify roles & responsibilities, and alignment on timelines
• Expertly utilize soft skills like leadership, communication, critical thinking and emotional intelligence to ensure team engagement and collaboration
• Successfully identify and remove road blocks that prevent meeting the project schedule.
• Identify when escalation is required to higher level management to mitigate critical project delays.
• Support Associate Director of Project Management with project tasks as requested
• Support development and standardization of PMO governance, process, and templates

Requirements

• Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific/technical discipline is required.
• PMP Training and Certification desired.
• Minimum 5 years’ experience in pharmaceutical industry including 3 years in increasingly complex project management duties in a GMP operations environment.
• Requires understanding of principles and qualification requirements for a range of systems and equipment, including ultrafiltration, CIP, chromatography, reactor tanks, centrifuges, filter presses, etc.
• Knowledge of cGMPs, FDA regulations, and industry guidelines.
• Strong technical writing skills.
• Ability to inspire high performance in others and align team.
• Ability to lead, motivate, guide, train, coach and develop personnel.
• Demonstrated project management skills.
• Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions.
• Must be proactive, results oriented, and have strong attention to detail.
• Self-starter with strong work ethic and the ability to exercise good judgment.
• Ability to effectively prioritize multiple tasks to meet deadlines.
• Strong interpersonal skills with the ability to interact with personnel at all levels in a team.

Tech Stack

• PMP

Benefits

• Medical
• Dental
• Vision
• Life insurance
• PTO
• Paid holidays
• Up to 5% 401(K) match
• Tuition reimbursement