The Bioanalytical Project Manager will act as an authoritative resource regarding the proper procedures and techniques required of the Project Management discipline. They will maintain a high level of responsibility for the conduct of projects and play an active role mentoring and guiding junior members of the Bioanalytical Study team. Additionally, they will act as the primary point of contact for external customers, providing exceptional customer service while ensuring that all work meets scientific standards and continually seeking out better ways to plan and execute projects. The Bioanalytical PM will also provide a strong leadership presence throughout the organization, driving quality science and process improvements.
location: Morrisville, North Carolina
job type: Permanent
salary: $100,000 - 110,000 per year
work hours: 9 to 5
- Provide oversight and conduct of a project throughout its life, 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 internal departments and Quality Assurance 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.
- Responds to unscheduled deadlines, client needs, and crises without neglecting other responsibilities.
- Demonstrated ability to manage high volume study work for key clients.
- Leads new employee training and develops training materials and schedules.
- Provides a technical resource for less experienced team members.
- 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 SOP requirements.
- Strong working knowledge of current regulatory guidelines (GLP, GCP).
- Ability to achieve results through collaborative efforts with others.
- In depth knowledge ligand binding and cell-based assays for Immunoassay and Immunogenicity.
- Experienced in sample extraction and routine laboratory procedures.
- 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.
skills: Molecular Biology
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.