Associate Project Manager, BioServices

Responsibilities

• Provide oversight and conduct of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis.
• Serve as Principal Investigator for GLP studies.
• Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs.
• Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business.
• Provide project trackers for client communications and lead regular teleconferences to discuss project progress.
• Coordinate customer visits and visit customers.
• Work with business development staff to prepare quotes and change orders for assigned customers.
• Prepare data for external presentations.
• Work closely with Medical Writing and QA to ensure project deliverables are completed on schedule.
• Monitor the progress of all assigned projects and alert management if work falls behind schedule.
• Accountable for budget across assigned project(s) including financial performance targets.
• Collaborate with finance to initiate monthly invoicing.
• Meet financial performance targets for the assigned projects and proactively manage change order process both internally and externally.
• Monitor project timeline and scope to ensure both remain on track; provide regular updates to management.
• Participate in weekly scheduling and revenue update meetings and provide updates on project progress.
• Ensure cross-functional collaboration among project team members including both internal and external services.
• Serve as escalation point for project issues.
• Resolve conflicts as needed.
• Proactively identifies ways to increase client satisfaction.
• Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
• Define and manage project resources.
• Ensure lessons learned are implemented across projects currently being managed.
• Contribute to development and management of client project metrics.
• Provide performance feedback of team members to respective supervisors.
• Serve as a scientific lead for non-regulated, GLP-regulated, and GCP-regulated studies.
• Review data (run binders, data tables, reports etc.) for regulatory compliance and scientific quality.
• Review and approve bioanalysis plans.
• Approve validation experimental designs and preparations.
• Lead method troubleshooting efforts and scientific investigations with assistance from the method developer; document investigation report.
• Address observations and findings from internal quality groups.
• Conduct thorough investigations of all failed runs and runs with analytical issues.
• Review validation and bioanalytical reports for completeness and scientific integrity.
• Coordinate sample shipments and data deliverables with internal and external CROs.
• Work with the customer or CRO to resolve sample discrepancies.
• Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices. Ensure projects are archived in accordance with Q2 Solutions SOP.
• Required Knowledge, Skills and Abilities

• Working knowledge of current regulatory guidelines (GLP, GCP)
• Ability to achieve results through collaborative efforts with others.
• Familiarity with liquid chromatography and combination with mass spectrometry or In vitro (Ithaca Site Location); Understanding of ligand binding and cell-based assays for Immunoassay and Immunogenicity (Marietta Site Location).
• Understanding of routine laboratory procedures.
• Understanding of method development and validation of assays.
• Ability to describe clearly experimental objectives and data conclusions.
• Proven ability to plan, prioritize, and manage a workload for large and complex projects
• Ability to interact with external and internal clients, and work to objectives/timelines
• Excellent attention to detail and communication skills
• Ability to follow verbally communicated procedures
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Minimum Required Education and Experience

• Bachelor's Degree in a scientific field with 5 years' related experience; or equivalent combination of education, training and experience in GLP laboratory environment.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status