Project Manager

Siegfried•Athens, GA

14d•$90,000 - $120,000

About The Position

The Project Manager leads complex new product development and introduction efforts under NPD/NPI procedures, as well as customer-driven CDMO projects. The role leads interdepartmental teams and coordinates resources across internal functions to deliver projects within scope, schedule, cost, and quality requirements. It also facilitates communication among project teams, customers, stakeholders, and senior management. Projects may involve external manufacturing networks, technical transfers, process improvements, and product line extensions. The position may require managing multiple projects concurrently and up to 25% travel to other facility locations.

Requirements

Bachelor’s degree in Chemistry, Chemical Engineering, or a related field.
At least 6 years of work experience in the pharmaceutical or biotech industry.
Experience with cGMPs at an FDA-regulated site, process safety practices, and environmental standards.
Ability to understand and apply knowledge of pharmaceutical active ingredient manufacturing, drug development, drug technology, and project management processes.
Ability to work effectively with others and with minimal supervision while coordinating multiple project priorities.
Strong computer skills, including hands-on experience with MS Office applications such as Excel, Word, and Project.
Ability to read, analyze, and interpret business, professional, technical, and regulatory materials; write reports, business correspondence, and procedures; present information and respond to questions; and perform technical writing.
Ability to apply mathematical concepts including exponents, logarithms, quadratic equations, and permutations, and understand control charts and statistical process control.
Ability to interpret written, oral, diagrammatic, and scheduled instructions; define problems, collect information, establish facts, and draw valid conclusions.
Ability to produce accurate, high-quality work in a timely manner, communicate clearly, convey technical information to nontechnical audiences, and coordinate multiple priorities.
Ability to comply with company policies and applicable regulations and guidelines, including FDA, EPA, OSHA, and DEA requirements.
Availability for scheduled or emergency overtime and up to 25% travel may be required.
Physical ability to frequently stand, walk, and use hands to finger, handle, or feel; occasionally sit, reach, climb or balance, stoop, kneel, crouch, or crawl; and occasionally lift or move up to 10 pounds. Close vision, color vision, and ability to adjust focus are required.

Nice To Haves

Advanced education.
Project management professional certification and/or business excellence certification.

Responsibilities

Build and lead multi-departmental teams through NPI/NPD projects across all seven program stages, from feasibility through aftercare.
Lead customer-driven CDMO projects from kickoff through completion and assist with assembling customer proposals.
Use business excellence and project management methods to develop workflows, manage risks, and deliver required Critical to Quality attributes and specifications.
Develop and justify specifications.
Cultivate internal relationships and partnerships; facilitate problem solving, conflict resolution, and meetings.
Coordinate with operations on scheduling, permits, capital appropriation, plant readiness, documentation, and SAP setup for new products.
Serve as the subject matter expert for project scope, product development, timelines, budgets, status, and interdependencies.
Communicate and track action items, milestones, and key decisions; provide project status updates to senior management and other organizational levels.
Maintain knowledge of cGMPs, process safety practices, environmental standards, and ICH guidelines.
Review and approve development and production documents, test procedures, and drug master file sections needed for new process introduction, validation, and regulatory submissions.
Execute technical transfers from development to production, internally or externally.
Manage multiple projects at different stages of NPI and development procedures.
Work autonomously, anticipate and resolve problems, and comply with EHS rules and practices; promptly report safety incidents, accidents, or injuries.
Serve as a liaison to external customers or suppliers as needed.
Manage commercial process improvement projects or line extension efforts as needed.
Produce accurate, high-quality work on schedule and communicate clearly and promptly, including technical information to nontechnical audiences.
Coordinate competing project priorities and work effectively across the organization to complete projects on time and within budget.
Comply with company and site policies, applicable state and federal regulations and guidelines, and relevant Environmental Management System requirements; complete required regulatory and job training.
Be available for scheduled or emergency overtime, travel up to 25% when required, and complete other assignments requested by management.