Immunoassay Bioanalytical Project Manager
The Bioanalytical Project Manager acts in a principle investigator role, and is the primary point of contact for external customers. The focus is to oversee the analysis of large molecule PK and immunogenicity studies and provide exceptional customer service while ensuring that all work meets Q2 Solutions’ scientific standards.
- Provide oversight and conduct of a project throughout its life, including method development, method validation, and sample analysis.
- Schedule daily resources to accomplish on time analysis.
- Work closely with Technical Writing and QA.
- Review data for regulatory compliance and scientific quality.
- Prepare data for external presentations.
- Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business.
- Coordinate customer visits.
- Work with business development staff to prepare quotes for new business.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Experienced in large molecule Ligand binding PK assay development, validation, and sample analysis
- Experienced in tiered Immunogenicity assays, cut point evaluation, validation, and sample analysis procedures
- Understanding of Immunoassay method development, validation, and sample analysis.
- Knowledge of WATSON LIMS, Softmax Pro, and MSD discovery workbench data handling and analysis software
- Excellent communication skills and attention to details
- Ability to interact with clients and oversee timelines.
- Ability to establish and maintain effective working relationships in a business matrix environment with coworkers, related departments, managers, and clients.
- Experience in a GLP compliant laboratory
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in life sciences or biochemistry field with 5 years related experience.
EEO Minorities/Females/Protected Veterans/Disabled
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