Company Overview:
Our client is a leading bioanalytical and biologics CMC analytical organization with operations in the San Francisco Bay Area and New Jersey. The team specializes in GLP-compliant bioanalytical and biomarker services, as well as CMC analytical support for biologics.
Position Summary:
The team is seeking a dedicated and detail-oriented Project Manager to oversee bioanalytical and biomarker service projects. This role involves coordinating cross-functional teams, maintaining client communications, and ensuring timely and compliant project execution.
Key Responsibilities:
• Manage the full lifecycle of studies, including method development, validation, sample/data analysis, and reporting.
• Collaborate with laboratory staff, data analysts, technical writers, QC, QA, procurement, and finance teams to ensure timely project completion.
• Serve as the primary point of contact for clients, providing regular updates and identifying opportunities for additional business.
• Resolve sample and data discrepancies in collaboration with clients.
• Monitor project timelines and alert management to any delays or risks.
• Maintain project trackers and lead regular client meetings to discuss progress.
• Define project scope, budget, and timelines; conduct periodic reviews to ensure alignment with expectations.
• Coordinate and host client visits as needed.
Qualifications:
• Bachelor's or Master's degree in biology, immunology, chemistry, pharmacology, or a related scientific field.
• Minimum of 3 years of experience in project management, preferably in a scientific or laboratory setting.
• Supervisory experience in project and/or team management is a plus.
• Familiarity with ligand binding assays, LC-MS/MS, cell-based assays, immunogenicity assays, PCR, and/or flow cytometry is advantageous.
• Knowledge of FDA/EMA regulations, GLP/GCLP standards, and ICH guidelines.
• Strong multitasking skills and the ability to manage multiple projects simultaneously.
• Excellent written, verbal, and interpersonal communication skills.
Preferred Skills:
• Proficiency in Microsoft Office and project management tools such as Smartsheet or Microsoft Project.
