Associate Project Manager, Bioservices (Remote)

Responsibilities

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

• Excellent attention to detail and communication skills
• Working knowledge of current regulatory guidelines (GLP, GCP)
• Ability to follow verbally communicated procedures
• 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).
• 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 achieve results through collaborative efforts with others.
• 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. About our Client With more than 9 million clinical laboratory tests managed annually, we are committed to providing our customers an innovative, progressive and responsive partner with the quality focus, global experience and deep medical expertise integral to drug, medical device and diagnostic development. We work collaboratively with our customers, business partners and colleagues to lead the industry and live our customer promise of providing Actionable Insights for Better Health™. Our commitment to innovation is how we’re building better clinical laboratory services for our customers’ – we call it “the lab of the future.” The lab of the future will help our customers develop drugs faster and more efficiently. Learn more about how we partner with our customers to build the lab of the future through: Tailored Solutions, Delivery Excellence and Shaping Outcomes. What we Offer
• Ability to interact with external and internal clients, and work to objectives/timelines
• Understanding of routine laboratory procedures.
• Understanding of method development and validation of assays.

• Annual bonus
• Other generous benefits
• 401(k) with 100% vesting after 2 years
• Generous paid time off and holiday leave
• Tuition Reimbursement up to $6k annually
• Major Medical, Vision, Dental, Disability

EEO Minorities/Females/Protected Veterans/Disabled

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