Job Description

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 Management * Lead 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 Communication
  • Serve 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 Management * Work 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 value * Track financial performance - including FTE utilization, planned vs actual hours, budget variance, and cash flow.
• Compliance & Quality
  • Ensure 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 Collaboration * Collaborate with cross-functional teams (Operations, QA, Sample Registration, Pricing, Business Development). * Collaborate with partner Eurofins sites and subcontractors as required.

Qualifications

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

Additional Information

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.