Scientific Project Manager
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.
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