QC PChem Manager
Company: Clene Nanomedicine
Location: North East
Posted on: June 24, 2022
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Job Description:
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.
Requirements:
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 Responsibilities
Maintains 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 improvement
Ensure 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 Responsibilities
This individual is responsible for all personnel assigned to the
Quality Control PChem lab which include QC Analysts and Lab
Technicians.
Competencies
Quality - 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.
PI179838774
Keywords: Clene Nanomedicine, Wilmington , QC PChem Manager, Executive , North East, Delaware
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