Project Manager (Bioanalytical)

Job Summary

The Project Manager will be responsible for providing technical project oversight and will act as a subject matter expert to a biopharmaceutical client tasked with managing and executing analytical testing, method development and/or transfer and validation of such assays as immunoassays, bioassays and/or pharmacokinetic assays under Good Laboratory Practices (GLP) or Good Clinical Practices (GCP). He/she will provide technical support to teams conducting training, technical transfer, data review and trending analysis. The Project Manager must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports.

Required Knowledge and Skills

• A thorough understanding of bioanalytical methods with a focus on immunogenicity and pharmacokinetics.

• Experience in bioanalytical method development, validation, formal technical transfer of methods and method performance monitoring.

• Strong assay and process troubleshooting skills.

• Strong communication skills.

• Cross-functional and cross-site team management experience.

• CRO performance and relationship management experience.

• Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA)

• Proficiency in technical writing and document control.

• Common and specialized computer software application proficiency and adaptability.

Essential Duties and Responsibilities

• Provide project management oversight and subject matter expertise in bioanalytical and pharmacokinetic testing, method development, validation and technical transfer to ensure scientific integrity and adherence to the protocol/plan/contracts and applicable regulations.

• Interact with U.S. and international CROs and effectively communicate updates, reports and recommendations to management teams.

• Provide analytical project oversight by performing data review and trending analysis, evaluate assay quality, monitor performance and manage timelines.

• Provide technical support to troubleshoot specific issues that impact the project.

• Manage Supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement.

• Recommend and implement new processes and procedures to standardize, simplify and enhance quality and compliance of the department’s operations.

• Expected to participate in the management and control of documentation and records, and contribute to and (co) author scientific and/or operational documents such as SOPs, validation protocols and reports, transfer protocols and reports, posters, journal publications and other technical reports.

Education/Experience

• M.S., Life Sciences or related field with a minimum of 2 years of industry-relevant project, laboratory and management experience, or

• B.S., Life Sciences or related field with a minimum of 5 years of industry-relevant project, laboratory and management experience