Entry Level Associate Project Manager: Biopharmaceutical Product Testing
On-siteLancaster, Pennsylvania, United States
Job Summary
Lead and manage multiple GMP testing projects from initiation to closure within a regulated laboratory environment. Establish comprehensive tracking tools, monitor progress, and implement mitigation strategies to ensure timely delivery and adherence to FDA, EMA, and ICH standards. Serve as the primary client contact, facilitating meetings, presenting KPIs, and managing turnaround time metrics while collaborating with cross-functional teams and partner sites. Prepare project updates, reports, and documentation to support audits and investigations. Track financial performance, including FTE utilization and budget variance, and work with Business Development to grow client relationships through cross-selling.
Required Qualifications
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
- 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
- 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
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