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.
Basic Minimum Qualifications:
- Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
- Authorization to work in the United States indefinitely without restriction or sponsorship
Preferred Qualifications:
- 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.
Position is Full-time, Monday-Friday, 8:00 a.m.-5:00 p.m., with overtime as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
This is an onsite position in Lancaster, PA with potential hybrid option after first year.
Excellent full-time benefits including:
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.