About this role
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
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be able to travel
Compensation:
• $32-55/h commensurate with experience