PAI I

ALIRI USA INC; Millcreek (UT); Presencial; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

ALIRI USA INC seeks a senior Laboratory Operations leader to drive efficient, GLP-compliant production and cross-functional collaboration. You will coordinate scheduling, forecasting, and resource allocation while interfacing with QA, Reporting, and clients.

The role requires strong analytical skills, MS analysis knowledge, and experience with regulatory guidance to ensure study integrity and timely delivery.

Formación

• Bachelor's degree in Chemistry or related field with 6–8+ years experience
• Master's degree or equivalent in Chemistry or related field with 5+ years experience
• Ph.D. or equivalent in Chemistry or related field with 2+ years experience
• Strong oral and written communication skills and customer interaction experience
• Solid understanding of GLP, regulatory guidance, and experimental design

Responsabilidades

• Plan, coordinate and organize productivity, scheduling, and forecasting resources cross-functionally
• Interface between Laboratory Operations, QA, and Reporting to ensure study alignment
• Communicate with the client, providing updates on ongoing programs and risks
• Engage Laboratory Operations throughout the productivity process and share impact of efforts
• Ensure studies meet protocol specifications and regulatory requirements
• Apply data evaluation tools to analyze analytical phase data and support study objectives

Conocimientos

Communication skills

Attention to detail

Oral and written communication

Mass spectrometry

HPLC

Instrumental analysis

Regulatory compliance

Project coordination

Educación

Bachelor's Degree in Chemistry or related Scientific field

Master's Degree or equivalent in Chemistry or related Scientific field

Ph.D. or equivalent in Chemistry or related Scientific field

Herramientas

Watson LIMS

Excel

JMP

Descripción del empleo

Primary Purpose:Help provide leadership that ensures efficient production that is scientifically sound and regulatory compliant.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 organizationPAIs to ensure projects are appropriately staffedActing as the interface between Laboratory Operations, QA, and Reporting • Scheduling and coordinating, including directing others, to ensure overall successful completion of studiesCommunicating frequently and effectively as the main point of contact with the client, providing updates on ongoing programsEngaging Laboratory Operations throughout the entire productivity process; planning, developing and implementing, as well as sharing impact of efforts, to discuss possible risks of projectsAdvocating for both the internal and external clientsUnderstanding and managing clients’ expectations with assistance as neededIncluding the entire project team in communications throughout projectEnsuring that all results meet internal and/or protocol specificationsEnsuring that the study design, results, and interpretation address changing stakeholder needsManage 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 ensure execution:a) Relating analytical data to study objectives as the study progresses, in “real time” b) Reviewing technical dataManaging studies to meet GLP, CDER, CVM, ICH, FIFRA, VICH, or applicable regulatory guidanceWriting content for technical-regulatory study protocols, plans, and reportsReconciling data and report reviews, as well as archival approvalApplying data evaluation techniques and tools (e.g., Analyst, JMP, Microsoft Excel, etc.) to assess analytical phase dataWorking Conditions:Office environment with occasional laboratory exposureEssential physical requirements include going up/down stairs, typing, and sitting or standing for long periodsPhysical 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 absencesNo travel requirements unless attending off-site trainingExperience:Bachelor's Degree in Chemistry or related Scientific field with 6-8+ years experience is required -OR-Master's Degree or equivalent in Chemistry or related Scientific field with 5+ years' experience is required -OR-Ph.D. or equivalent in Chemistry or related Scientific field with 2+ years experience is required*Significant work experience will be considered as a substitution for educationKnowledge, Skills, and Abilities:General understanding of the technical knowledge to ensure operational efficiency of Laboratory Operations within the business programGeneral knowledge of instrumental analysis, including mass spectrometry and chromatographyGeneral knowledge of current industry guidance and regulationsOral and written communication skills, including comfort in calling and talking with customers on the telephone, when in-person interactions are not possibleStrong attention to detail; the ability to manage large numbers of competing requirements is absolutely mandatoryGeneral understanding of customer perspective for bioanalytical regulatory development programsRelevant expertise to ensure technical quality, suitability of data for the intended purpose, and operational efficiency of projects executionGeneral GLP regulatory and experimental design experiencePreferred Qualifications:Mass spectrometry or HPLC experience.Advanced knowledge of Watson LIMS.Advanced knowledge of Excel.Current experience with industry and regulatory guidance