PAI II

Job DetailsJob Location: COLORADO SPRINGS, CO 80907Salary Range: $100,000.00 - $130,000.00 Salary/yearPrimary 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

Managing studies to meet GLP, CDER, CVM, ICH, FIFRA, VICH, or applicable regulatory guidance
Writing content for technical-regulatory study protocols, plans, and reports
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

QualificationsExperience:

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 understanding of the technical knowledge to ensure operational efficiency of

Laboratory Operations within the business program

Proficient knowledge of instrumental analysis, including mass spectrometry and chromatography
General knowledge of current industry guidance and regulations
Ability to build lasting client relationships and support marketing and sales activities •      Strong oral and written communication skills, including very strong bias toward calling and talking with customers on the telephone, when in-person interactions are not possible
Very strong attention to detail; the ability to manage large numbers of competing requirements is absolutely mandatory
Understanding of customer perspective for bioanalytical regulatory development programs
Technical expertise to ensure technical quality, suitability of data for the intended purpose, and operational efficiency of projects execution
GLP regulatory and experimental design experience
Forecasting, planning, and interdepartmental facilitation skills
Integrating the commercial and technical aspects of laboratory operations

Preferred Qualifications:

 Mass spectrometry or HPLC experience.

Advanced knowledge of Watson LIMS.

Advanced knowledge of Excel.

Current experience with industry and regulatory guidance