Associate Project Manager, Bioservices (Remote)

Responsibilities

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

Required Knowledge, Skills and Abilities

• Understanding of routine laboratory procedures.
• Working knowledge of current regulatory guidelines (GLP, GCP)
• Excellent attention to detail and communication skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• 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 interact with external and internal clients, and work to objectives/timelines
• Understanding of method development and validation of assays.
• Ability to achieve results through collaborative efforts with others.
• Ability to follow verbally communicated procedures

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

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

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