About this role
Role Overview
The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing Good Manufacturing Practice (GMP)-compliant testing projects within a regulated laboratory environment. This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams and external clients.
Key Responsibilities
Project ManagementLead and manage multiple GMP testing projects from initiation to closure.Establish and maintain comprehensive tracking tools for projects, including schedules, action trackers and dashboards to enforce accountability and timely delivery.Monitor progress, identify risks, and implement mitigation strategies.Ensure all deliverables meet client expectations and regulatory requirements.Prepare and present project updates and reports to internal and external stakeholders.Track, manage and report turnaround time metrics and schedule variance. Client CommunicationServe as the primary point of contact for clients, ensuring clear communication and accurate interpretation of technical data across functional teams.Organize and facilitate planned and ad hoc project meetings including: project kick off, recurring project status calls, client technical visits, and project closure meetings.Prepare and present project status and performance KPIs in client Business Review Meetings.Financial ManagementWork closely with the Business Development team to grow client relationship and revenue through cross selling and managing assigned projects to provide exemplary customer experience and valueTrack financial performance - including FTE utilization, planned vs actual hours, budget variance, and cash flow. Compliance & QualityEnsure testing activities comply with GMP, GLP, and relevant regulatory guidelines.Maintain accurate documentation in accordance with Quality Management Systems (QMS).Support audits and inspections by regulatory authorities and clients.Drive investigations to timely closure.Team CollaborationCollaborate with cross-functional teams (Operations, QA, Sample Registration, Pricing, Business Development).Collaborate with partner Eurofins sites and subcontractors as required. Qualifications
Education:
Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
Experience:Strong background in pharmaceutical sciences, analytical chemistry, or biologics.Experience in GMP lab operations, especially in CMC testing.Proven ability to manage complex projects and cross-functional teams.Familiarity with regulatory requirements and quality standards.Excellent communication and client management skills.Skills:Knowledge of GMP regulations (21 CFR Part 210/211, EU GMP).Excellent organizational and time-management skills.Proficiency in project management tools (MS Project, Smartsheet).Strong communication and stakeholder management abilities.Authorization to work in the United States indefinitely without restriction or sponsorship Position is full-time, Monday-Friday, 8:00 a.m.-4:00 p.m Hours are flexible. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
We offer excellent full-time benefits including:
comprehensive medical coverage,life and disability insurance,401(k) with company match,paid holidays and vacation, dental and vision options.Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.