Additionalinformation

Additional Information

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.

Companydescription

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Jobdescription

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

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.