8339 Senior BioAnalytical Project Manager
The individual in this position is a key contributor supporting the BAS organization by working with cross-functional teams to oversee and manage Contract Research Organizations (CROs) capable of supporting PK and ADA assays as well as biomarker assays across various technology platforms.
This individual will effectively oversee assay transfer and qualification/validation timelines enabling sample testing for both non-clinical and clinical studies.
An ability to communicate effectively across multiple functional areas and programs is key.
Individuals must have a strong understanding of science, technology and CRO landscape.
The Senior BioAnalytical Project Manager applies an understanding of the principles of bioanalytical requirements and processes related to assay method development and validation, sample analysis and data management of outsourced assays to bioanalytical labs.
The responsibilities for a Senior BioAnalytical Project Manager in an outsourcing lead role may include:
Lead outsourcing activities and oversight for assigned CROs in support of clinical and/or nonclinical assays with a strong understanding of disease indication, MOA, clinical strategy and bioanalytical strategy.
As the operational contact for specific CRO partners, will work to cultivate and maintain productive working relationships.
Facilitates assay transfer, validation, and implementation of bioanalytical methods at CRO laboratories to enable sample testing for clinical and non-clinical studies.
Leverages scientific knowledge to identify CROs with particular platform/skill requirement.
Effectively develops and tracks project timelines of BAS outsourced studies utilizing Workfront and other various systems and platforms.
Through innovation, improve processes for efficiency and simplicity.
Responsible for specific vendor Service Provider Oversight Plan.
Maintains CRO performance indicators/metrics with a comprehensive understanding of portfolio needs and priorities.
Through vendor oversight, develop an understanding of general Quality approaches and processes at assigned CROs specific to the execution of procedures enabling delivery of high quality data.
Offers support to peers through knowledge sharing and cooperation.
Maintains an optimistic attitude under pressure.
Maintain required training and apply relevant regulatory compliance and internal business standards in the performance of job responsibilities.
Bachelor’s or higher degree in Biological Sciences or a related field.
8-11 years of experience working in the pharmaceutical or related industry, that includes applying analytical skills and judgment on bioanalytical data.
Ability to navigate to deliver results successfully in a highly matrixed organization, collaborating with multiple functions.
Strong organizational skills with attention to details.
Proven track record of independently managing multiple projects simultaneously.
Ability to prioritize and apply sound decision-making with limited information and understanding of broader business impact.
Excellent communication and presentation skills and effective influential and negotiation skills.
Detail oriented, with ability to multi-task and work in both an individual and team-based environment.
Working knowledge and/or hands-on experience with assay validation highly desirable.
Experience managing CROs on assay method transfers highly desirable.
Project management training/experience.
GCP/GLP knowledge and experience.