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QC PChem Manager

Company: Clene Nanomedicine
Location: North East
Posted on: May 16, 2022

Job Description:

The QC PChem Manager is the responsible individual who will oversee the Quality Control PChem laboratory. This individual is responsible for overseeing the physicochemical analysis of finished drug product, and research & development samples produced by Clene Nanomedicine. The individual will be required to follow all Standard Operating Procedures (SOPs); Good Manufacturing Practices (GMP), and internal processes.

Required Education and/or Experience A Bachelor's degree in the sciences is mandatory and advanced degree is preferred. This position prefers four years ' experience in a laboratory environment with management experience a plus. The employee shall be computer literate with excellent communication skills.Essential Duties and ResponsibilitiesMaintains compliance with Quality Assurance (QA) and control processes.Assist in development and oversight of key performance indicators (KPI's). Support personnel on 24/7 shift operation.Maintain acceptable level of laboratory operational performance and adjusts when performance reaches an unacceptable level. Uphold rapid turn-around times of samples by effectively managing staff and utilizing resources while maintaining high standards of accuracy. Committed to continuous process improvement to improve efficiency.Oversee the development and implementation of quality measures; in accordance with standardized procedures, develop and implement new laboratory procedures as necessary to improve laboratory workflow and overall operations; and provide recommendations and follow up actions on areas that need improvementEnsure compliance with laboratory regulations and safety standards.Consistently manages inventory to ensure the lab is well stocked with supplies and works closely with procurement to ensure supplies are reaching the laboratory.Consult with outside GMP consultants to generate robust validation documents.Oversee the execution of quality control validations and statistical analysis.Write validations and reports.Oversee the analytical characterization of submitted nanoparticle suspensions using the following equipment: CEM Discover SPD microwave digester Agilent ICP-MS 7700x Malvern Zetasizer ZS90 ThermoFisher UV-Vis pH/conductivity meter Shimadzu TOC-Vwp Shimadzu DSC Shimadzu FTIR Other equipment as required Follow cGMP and cGLP standards and SOPs.Attend as necessary and successfully complete training on analytical instrumentation and procedures as well as other directed areas of interest.Oversee the Calibration and Preventative Maintenance within the lab.Lead training of new personnel and ensure all personnel are properly trained.Manage the hiring, training, and performance evaluations of Lab Personnel.Performs other duties as assigned.Supervisory ResponsibilitiesThis individual is responsible for all personnel assigned to the Quality Control PChem lab which include QC Analysts and Lab Technicians.CompetenciesQuality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Follows cGMPs, TSMs, and SOPs.Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities arecovered when absent; Arrives at meetings and appointments on time.Schedule: Ability to work shift scheduling including weekends and Holidays. Available to Analysts and Technicians for trouble shooting and questions. Must be able to interface with all levels of personnel in a professional manner.PI175595220

Keywords: Clene Nanomedicine, Wilmington , QC PChem Manager, Executive , North East, Delaware

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