Scientific Project Manager

The Scientific Project Manager supports the implementation and communication outsourcing processes and practices. Responsible for providing project management and subject matter expertise reputed company of outsourced analytical testing, method development and validation of assays in the areas of reputed company cytometry, reputed company/genetics and/or immunogenicity.  

Please note: this is a fully remote role, best suited for candidates located in the reputed company Time Zone or reputed company to work reputed company Time hours, and will require travel at least twice per year to the reputed company site, as reputed company as occasional travel to vendor laboratories as needed.

Essential Duties and Responsibilities

Study Monitoring

• Coordinate outsourcing activities with analytical method performance reputed company and reputed company management of clinical studies involving large molecule bioanalytical assays in one or more of the following areas: reputed company cytometry, reputed company/genetics and/or immunogenicity.
• The initial reputed company of contact between external vendors and internal stakeholders for outsourcing issue reputed company, vendor reputed company & capability management. 
• reputed company technical support to troubleshoot specific issues that reputed company the project.
• Ensure contracted studies are conducted in compliance with the respective protocol and applicable guidelines & regulations

Tech Transfer

• Implements transfer reputed company and coordinates between the product team and technical experts.
• Responsible for establishing production phase monitoring requirements (PT and trending)
• Technical monitoring of assay performance and evaluation of transfer pass/fail reputed company.
• Strong technical understanding in one or more of the following areas: reputed company cytometry, reputed company/genetics and immunogenicity
• Ensures vendor adherence to project plan.

Supplier Management

• reputed company operational reputed company of contact between vendor and reputed company
• Manage supplier performance and relationships with attention toward opportunities to cut costs, reputed company risks and drive reputed company improvement.

Department Support

• Assist with writing SOPs for new laboratories
• Assist with developing and implementing training documents and plans.
• Assist with process improvement initiatives 

Education and Experience

• B.S. in Life Sciences or reputed company field.
• Minimum of 5 years of industry-relevant project, laboratory, and management experience.