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Skills
Biologyunmatched
Clinical Trialunmatched
Develop Methodologiesunmatched
Drug Developmentunmatched
Facilities and Maintenanceunmatched
Identify Issuesunmatched
Leadershipunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Problem Solving Skillsunmatched
Procedure Developmentunmatched
Process Validationunmatched
Research & Development (R&D)unmatched
Safety/Work Safetyunmatched
Standard Operating Procedures (SOP)unmatched
Team Lead/Managerunmatched
Willing to Travelunmatched
Description
Responsibilities
Lead team of Technicians manufacturing of supplies for development and clinical studies
Independently perform a variety of highly complex tasks to support R&D and development activities
Interact with R&D and Technical Services personnel to provide input and expertise and to assist in the optimization processes
Independently set-up, operate, troubleshoot and dismantle a broad range of equipment (bench-top, medium, large scale used for the manufacturing of Nova Pneuma Inc products
Lead and coordinate the execution of experimental, clinical and process qualification and validation activities
Lead select manufacturing processes and initiate investigations when deviations occur
Assume the responsibilities of Supervisor when absent
Generate and revise SOPs, Production Records and IOQ documents
Provide leadership and direction to Technicians when needed
Provide on-the-job and SOP training including facilitating group training
Ensure a safe work environment is maintained and initiate and investigate Safety Incident Reports when they occur
Interact with Maintenance and Facilities to ensure equipment and facilities are maintained in good working order
Ensure that all pertinent issues are communicated between shifts (as required)
Skills required
As a highly skilled specialist, contributes to the development of concepts and techniques.
Completes complex tasks in creative and effective ways.
Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues. Makes recommendations for new procedures.
Acts independently to determine methods and procedures on new assignments.
Often acts as a facilitator and team leader.
Education and experience
A high school diploma or equivalent experience
6+ years experience in the biopharmaceutical or medical device industry
AA or AS in a Life Sciences or Engineering discipline preferred
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer