PAI II

# PAI II COLORADO SPRINGS, CO 80907;
Remote, CO 80907;
Millcreek , UT 84106## Overview Salary Range$ - $ Salary/year## Description Primary

Purpose:

Provide leadership that ensures efficient production that is scientifically sound and regulatory compliant. Responsible for helping implement efficiency improvements in overall productivity.

Job Duties and Responsibilities:

* Planning, coordinating and organizing, including efficient productivity, scheduling, and forecasting resources (e.g., liaising with different departments to working on allocation, utilization and direction of company resources cross-functionally)
* Maintaining knowledge of status/progress for projects across different departments
• Monitoring productivity to help meet monthly revenue goals and overall goals of the organization
* Ensure incoming projects are feasible from an overall organizational standpoint so that Aliri  Labs Inc. can successfully meet client deliverables
* Acting as the interface between Laboratory Operations, QA, and Reporting
• Scheduling and coordinating, including directing others, to ensure overall successful completion of studies
* Communicating frequently and effectively as the main point of contact with the client, providing updates on ongoing programs
* Engaging Laboratory Operations throughout the entire productivity process; planning, developing and implementing, as well as sharing impact of efforts, including helping distribute risk evenly between all projects
• Advocating for both the internal and external clients
* Completely understanding and managing clients’ expectations
* Including the entire project team in communications throughout project
* Ensuring that all results meet internal and/or protocol specifications
* Ensuring that the study design, results, and interpretation address changing stakeholder needs
* Manage studies; project initiation planning; helps both customers and laboratory staff to interpret data and adjusts the bioanalytical development approach.  Support internal resources and customers by applying current scientific, regulatory, and  project management expertise to establish experimental design and support execution: a) Relating analytical data to study objectives as the study progresses, in “real time” b) Reviewing technical data
1. Managing studies to meet GLP, CDER, CVM, ICH, FIFRA, VICH, or applicable regulatory guidance
2. Writing content for technical-regulatory study protocols, plans, and reports
3. Reconciling data and report reviews, as well as archival approval
* Applying data evaluation techniques and tools (e.g., Analyst, JMP, Microsoft Excel, etc.) to assess analytical phase data Understand the business need for each project and make on-going decisions based on what’s best for the organization—even if that means challenging senior stakeholders on critical success factors.

Working Conditions:

* Office environment with occasional laboratory exposure
* Essential physical requirements include going up/down stairs, typing, and sitting or standing for long periods
* Physical effort requirements are moderate (ranging from sedentary to lifting boxes up to 10-15 pounds)
* Occasional long hours and/or weekends during peak production cycles and/or staff absences
* No travel requirements unless attending off-site training## Qualifications

Experience:

Bachelor's Degree in Chemistry or related Scientific field with 8-10+ years experience is required
-OR-Master's Degree or equivalent in Chemistry or related Scientific field with 7+ years experience is required
-OR-Ph.D. or equivalent in Chemistry or related Scientific field with 5+ years experience is required  
* Significant work experience will be considered as a substitution for education Knowledge, Skills, and Abilities:  
* Strong…